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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The goal of this study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each are combined with two other antiretroviral agents, in patients who are previously naive to antiretroviral therapy. This study will involve approximately 200 centers from around the world to achieve a total randomized subject population of 1071 subjects. Patients will be randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks of treatment. This may be extended for an additional 3 years depending on the results at 96 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be performed, at selected centers, at study entry and week 96. Patients will be asked to complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 3 | Active Comparator |
| |
| 2 | Experimental | Following a review of the interim analysis data, the DSMB recommended to terminate the UK-427,857 300 mg QD arm based on pre-specified protocol non-inferiority criteria not being met for the QD arm versus efavirenz |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc + Zidovudine/Lamivudine | Drug | maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population | Week 48 | |
| Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population | Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression | Week 48 | |
| Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 96 | Week 96 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35233 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30192390 | Derived | Vourvahis M, McFadyen L, Nepal S, Valluri SR, Fang A, Fate GD, Wood LS, Marshall JC, Chan PLS, Nedderman A, Haynes J, Savage ME, Clark A, Smith KY, Heera J. No Clinical Impact of CYP3A5 Gene Polymorphisms on the Pharmacokinetics and/or Efficacy of Maraviroc in Healthy Volunteers and HIV-1-Infected Subjects. J Clin Pharmacol. 2019 Jan;59(1):139-152. doi: 10.1002/jcph.1306. Epub 2018 Sep 7. | |
| 21388938 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Data Safety Monitoring Board (DSMB) recommended termination of maraviroc once daily treatment after interim analysis at nominal week 16, 130 participants of 177 randomized were switched to open-label (OL) maraviroc twice daily.
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| ID | Title | Description |
|---|---|---|
| FG000 | Maraviroc Once Daily + CBV (DB) | Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant's Week 96 visit. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind (DB) Phase |
|
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| Efavirenz + Zidovudine/Lamivudine | Drug | efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily) |
|
| Maraviroc (UK-427,857) + Zidovudine/Lamivudine | Drug | maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) |
|
| Week 96 |
| Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96 | Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. | Baseline, Week 48, Week 96 |
| Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels | TAD from baseline was calculated as area under the curve (AUC) of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. | Baseline up to Week 48 and Week 96 |
| Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96 | Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. | Baseline, Week 48, Week 96 |
| Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96 | Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. Change from baseline in lymphocyte CD8 count at Week 48 and 96 was not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. | Baseline, Week 48, Week 96 |
| Time to Virologic Failure | Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU. | Week 48, Week 96 |
| Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48 | Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure: discontinuation due to insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as last on treatment assessment. | Baseline, time of failure through Week 48 |
| Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96 | Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 96 visit. Treatment failure defined as insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as BLQ. The assessment for time of treatment failure was defined as last on treatment assessment. | Baseline, time of failure through Week 96 |
| Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96 | Phenotypic resistance to nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) assessed at screening by Monogram Bioscience PhenoSense genotype (MBPSGT) assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Phenotypic resistance to maraviroc was assumed in maraviroc treatment failures with X4-using virus and in R5 maraviroc treatment failures using Monogram Bioscience PhenoSense Entry Assay. Phenotypic resistance to zidovudine, lamivudine, efavirenz and maraviroc at time of failure was summarized. | Screening, time of failure through Week 48, Week 96 |
| Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96 | Genotypic resistance to NRTIs was assessed by identification of relevant mutations at screening using MBPSGT assay and repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure through week 48 and week 96. Following mutations associated with NRTIs were summarized at time of failure: Any zidovudine/lamivudine (Zid/Lam), Any thymidine analogue-associated mutation (TAM), methionine (M) to valine/isoleucine (V/I) substitution at residue (r) 184 (M184V/I), lysine (K) to arginine (R) substitution at residue 65 (K65R) and any other NRTI mutations. | Screening, time of failure through Week 48, Week 96 |
| Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96 | Genotypic resistance: mutations at screening by MBPSGT assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Efavirenz mutation:lysine to aspargine at r103(K103N);tyrosine to cysteine/isoleucine at r181(Y181C/I);tyrosine to cysteine/leucine/histidine at r188(Y188C/L/H);glycine to alanine/serine at r190(G190A/S);valine to alanine to r106(V106A);leucine to isoleucine at r100(L100I);alanine to glycine at r98(A98G);lysine to glutamic acid at r101(K101E);valine to isoleucine at r108(V108I);proline to histidine at r225(P225H);methionine to leucine at r230(M230L). | Screening, time of failure through Week 48, Week 96 |
| Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening | Association between baseline resistance and virological response was assessed as percentage of participants with HIV-1RNA levels less than 50 copies/mL by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. | Baseline, Week 48, Week 96 |
| Birmingham |
| Alabama |
| 35294-2050 |
| United States |
| Pfizer Investigational Site | Beverly Hills | California | 90211 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90022 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90048 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90069 | United States |
| Pfizer Investigational Site | Newport Beach | California | 92663 | United States |
| Pfizer Investigational Site | Oakland | California | 94602 | United States |
| Pfizer Investigational Site | Sacramento | California | 95825 | United States |
| Pfizer Investigational Site | San Francisco | California | 94115-3029 | United States |
| Pfizer Investigational Site | San Francisco | California | 94115 | United States |
| Pfizer Investigational Site | Aurora | Colorado | 80045 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32209 | United States |
| Pfizer Investigational Site | Miami | Florida | 33133 | United States |
| Pfizer Investigational Site | Miami | Florida | 33136 | United States |
| Pfizer Investigational Site | Miami Beach | Florida | 33139 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32803 | United States |
| Pfizer Investigational Site | Sarasota | Florida | 34243 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33614 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30308 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60611 | United States |
| Pfizer Investigational Site | Indianapolis | Indiana | 46202 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21201 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02111 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02118-2393 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02215 | United States |
| Pfizer Investigational Site | Springfield | Massachusetts | 01107 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68106 | United States |
| Pfizer Investigational Site | Albany | New York | 12208 | United States |
| Pfizer Investigational Site | Brooklyn | New York | 11203 | United States |
| Pfizer Investigational Site | Flushing | New York | 11355 | United States |
| Pfizer Investigational Site | Manhasset | New York | 11030 | United States |
| Pfizer Investigational Site | New York | New York | 10016 | United States |
| Pfizer Investigational Site | Huntersville | North Carolina | 28078 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45267-0405 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73104-5068 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29206 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75208 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Houston | Texas | 77006 | United States |
| Pfizer Investigational Site | Houston | Texas | 77098 | United States |
| Pfizer Investigational Site | Annandale | Virginia | 22003 | United States |
| Pfizer Investigational Site | Puyallup | Washington | 98372 | United States |
| Pfizer Investigational Site | Tacoma | Washington | 98405 | United States |
| Pfizer Investigational Site | El Palomar | Buenos Aires | 1684 | Argentina |
| Pfizer Investigational Site | Neuquén | Neuquén Province | Q8300PMB | Argentina |
| Pfizer Investigational Site | Buenos Aires | Argentina |
| Pfizer Investigational Site | Ciudad de Buenos Aires | C1202ABB | Argentina |
| Pfizer Investigational Site | Ciudad de Buenos Aires | C1406FWY | Argentina |
| Pfizer Investigational Site | Ciudad de Buenos | C1282AEN | Argentina |
| Pfizer Investigational Site | Provincia de Buenos Aires | Argentina |
| Pfizer Investigational Site | Provincia de Santa Fe | Argentina |
| Pfizer Investigational Site | Burwood | New South Wales | 2134 | Australia |
| Pfizer Investigational Site | Darlinghurst | New South Wales | 2010 | Australia |
| Pfizer Investigational Site | Surrey Hills | New South Wales | 2010 | Australia |
| Pfizer Investigational Site | Wentworthville | New South Wales | 2145 | Australia |
| Pfizer Investigational Site | Herston | Queensland | 4029 | Australia |
| Pfizer Investigational Site | Miami | Queensland | 4220 | Australia |
| Pfizer Investigational Site | Fitzroy North | Victoria | 3068 | Australia |
| Pfizer Investigational Site | Melbourne | Victoria | 3004 | Australia |
| Pfizer Investigational Site | South Yarra | Victoria | 3141 | Australia |
| Pfizer Investigational Site | Brussels | 1000 | Belgium |
| Pfizer Investigational Site | Brussels | 1200 | Belgium |
| Pfizer Investigational Site | Ghent | 9000 | Belgium |
| Pfizer Investigational Site | Leuven | B-3000 Leuven | Belgium |
| Pfizer Investigational Site | Rio de Janeiro | Rio de Janeiro | 20210-030 | Brazil |
| Pfizer Investigational Site | Calgary | Alberta | T2R0X7 | Canada |
| Pfizer Investigational Site | Edmonton | Alberta | T6G 2B7 | Canada |
| Pfizer Investigational Site | Edmonton | Alberta | T6G 2C8 | Canada |
| Pfizer Investigational Site | Vancouver | British Columbia | V6B 1R3 | Canada |
| Pfizer Investigational Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Pfizer Investigational Site | Vancouver | British Columbia | V6Z 2C7 | Canada |
| Pfizer Investigational Site | Vancouver | British Columbia | V6Z 2T1 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Pfizer Investigational Site | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Pfizer Investigational Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| Pfizer Investigational Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M4N 3M5 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5B 1W8 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5G 2N2 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H2L 4M1 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H2L 4P9 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H2L 5B1 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H2W 1T8 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H2X 2P4 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H3G 1A4 | Canada |
| Pfizer Investigational Site | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| Pfizer Investigational Site | Antella (FI) | 50011 | Italy |
| Pfizer Investigational Site | Brescia | 25123 | Italy |
| Pfizer Investigational Site | Milan | 20127 | Italy |
| Pfizer Investigational Site | Modena | 41100 | Italy |
| Pfizer Investigational Site | Roma | 00161 | Italy |
| Pfizer Investigational Site | Roma | 00185 | Italy |
| Pfizer Investigational Site | Torino | 10149 | Italy |
| Pfizer Investigational Site | Del. Tlalpan C.P. | Mexico City | 14050 | Mexico |
| Pfizer Investigational Site | Del. Tlalpan, C.P. | Mexico City | 14000 | Mexico |
| Pfizer Investigational Site | Del. Tlalpan, C.P. | Mexico City | 14080 | Mexico |
| Pfizer Investigational Site | Delegacion Tlalpan C. P | Mexico City | 14080 | Mexico |
| Pfizer Investigational Site | Amsterdam | 1091 AC | Netherlands |
| Pfizer Investigational Site | Rotterdam | 3015 GD | Netherlands |
| Pfizer Investigational Site | Utrecht | 3584 CX | Netherlands |
| Pfizer Investigational Site | Bialystok | 15-540 | Poland |
| Pfizer Investigational Site | Bydgoszcz | 85-030 | Poland |
| Pfizer Investigational Site | Chorzów | 41-500 | Poland |
| Pfizer Investigational Site | Gdansk | 80-214 | Poland |
| Pfizer Investigational Site | Krakow | 31-531 | Poland |
| Pfizer Investigational Site | Szczecin | 71-455 | Poland |
| Pfizer Investigational Site | Warsaw | 01-201 | Poland |
| Pfizer Investigational Site | Ponce | 00731 | Puerto Rico |
| Pfizer Investigational Site | Rio Piedras | 00935 | Puerto Rico |
| Pfizer Investigational Site | San Juan | 00909 | Puerto Rico |
| Pfizer Investigational Site | San Juan | 00935 | Puerto Rico |
| Pfizer Investigational Site | Port Elizabeth | Eastern Cape | 6065 | South Africa |
| Pfizer Investigational Site | Bloemfontein | Free State | 9300 | South Africa |
| Pfizer Investigational Site | Johannesburg | Gauteng | 2092 | South Africa |
| Pfizer Investigational Site | Pretoria | Gauteng | 0083 | South Africa |
| Pfizer Investigational Site | Dundee | KwaZulu-Natal | 3000 | South Africa |
| Pfizer Investigational Site | Bloomfontein | South Africa |
| Pfizer Investigational Site | Cape Town | 7405 | South Africa |
| Pfizer Investigational Site | Cape Town | 7550 | South Africa |
| Pfizer Investigational Site | Cape Town | 7705 | South Africa |
| Pfizer Investigational Site | Cape Town | 7780 | South Africa |
| Pfizer Investigational Site | Johannesburg | 2047 | South Africa |
| Pfizer Investigational Site | Pretoria | 0132 | South Africa |
| Pfizer Investigational Site | Pretoria North | 0182 | South Africa |
| Pfizer Investigational Site | Soweto, Johannesburg | 2013 | South Africa |
| Pfizer Investigational Site | Basel | 4031 | Switzerland |
| Pfizer Investigational Site | Bern | 3010 | Switzerland |
| Pfizer Investigational Site | Geneva | 1211 | Switzerland |
| Pfizer Investigational Site | Lugano | 6900 | Switzerland |
| Pfizer Investigational Site | Sankt Gallen | 9007 | Switzerland |
| Pfizer Investigational Site | Zurich | 8038 | Switzerland |
| Pfizer Investigational Site | Zurich | 8091 | Switzerland |
| Pfizer Investigational Site | Edinburgh | Loth | ED4 2XU | United Kingdom |
| Pfizer Investigational Site | Birmingham | B9 5SS | United Kingdom |
| Pfizer Investigational Site | Brighton | BN2 1ES | United Kingdom |
| Pfizer Investigational Site | Edinburgh | EH4 2XU | United Kingdom |
| Pfizer Investigational Site | London | NW3 2QG | United Kingdom |
| Pfizer Investigational Site | London | SE5 9RS | United Kingdom |
| Pfizer Investigational Site | London | SW10 9NH | United Kingdom |
| Pfizer Investigational Site | London | W2 1NY | United Kingdom |
| Pfizer Investigational Site | Manchester | M8 5RB | United Kingdom |
| Derived |
| MacInnes A, Lazzarin A, Di Perri G, Sierra-Madero JG, Aberg J, Heera J, Rajicic N, Goodrich J, Mayer H, Valdez H. Maraviroc can improve lipid profiles in dyslipidemic patients with HIV: results from the MERIT trial. HIV Clin Trials. 2011 Jan-Feb;12(1):24-36. doi: 10.1310/hct1201-24. |
| 20949133 | Derived | Funderburg N, Kalinowska M, Eason J, Goodrich J, Heera J, Mayer H, Rajicic N, Valdez H, Lederman MM. Effects of maraviroc and efavirenz on markers of immune activation and inflammation and associations with CD4+ cell rises in HIV-infected patients. PLoS One. 2010 Oct 6;5(10):e13188. doi: 10.1371/journal.pone.0013188. |
| 20151839 | Derived | Cooper DA, Heera J, Goodrich J, Tawadrous M, Saag M, Dejesus E, Clumeck N, Walmsley S, Ting N, Coakley E, Reeves JD, Reyes-Teran G, Westby M, Van Der Ryst E, Ive P, Mohapi L, Mingrone H, Horban A, Hackman F, Sullivan J, Mayer H. Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection. J Infect Dis. 2010 Mar 15;201(6):803-13. doi: 10.1086/650697. |
| FG001 | Maraviroc Twice Daily + CBV (DB and OL) | Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase. |
| FG002 | Efavirenz Once Daily + CBV (DB and OL) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase. |
| FG003 | Maraviroc Twice Daily + CBV (OL) | Participants who received maraviroc 300 mg tablet orally once daily treatment during the DB phase and who were eligible based on safety criteria and virologic response, switched to OL maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, following the DSMB recommendation to terminate the maraviroc once daily treatment arm after planned interim analysis. OL phase continued for at least 3 years after DB phase. |
| FG004 | Maraviroc Twice Daily + CBV (SP) | Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Between DB and OL Phase |
|
|
| Open-label (OL) Phase |
|
|
| Supplemental Phase (SP) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Maraviroc Once Daily + CBV (DB) | Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant's Week 96 visit. |
| BG001 | Maraviroc Twice Daily + CBV (DB and OL) | Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase. |
| BG002 | Efavirenz Once Daily + CBV (DB and OL) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, up to week 96 in DB phase. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily from Week 97 up to Week 240 in open-label (OL) phase. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F). | Posted | Number | Percentage of participants | Week 48 |
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| Primary | Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population | Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. | Per protocol (PP) population included all randomized participants who had taken at least 1 dose of study medication, were treated for at least 14 days or discontinued before this time due to treatment failure, were >80% compliant with randomized treatment and had no violation of any inclusion or exclusion criteria, which affected efficacy. MD=F. | Posted | Number | Percentage of participants | Week 48 |
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| Secondary | Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F). | Posted | Number | Percentage of participants | Week 48 |
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| Secondary | Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F). | Posted | Number | Percentage of participants | Week 96 |
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| Secondary | Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96 | Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. | FAS population. Missing values for viral load at week 48 and 96 were imputed as baseline value for participants who discontinued and as last observation carried forward (LOCF) for participants who did not discontinue for maraviroc twice daily and efavirenz once daily arm and as LOCF for participants randomized to maraviroc once daily arm. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Week 48, Week 96 |
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| Secondary | Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels | TAD from baseline was calculated as area under the curve (AUC) of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. TAD imputed as 0 for participants who discontinued. TAD calculated using the last non-missing value prior to the analysis time point for participants with a missing value at the analysis time point but who had not discontinued. | Posted | Least Squares Mean | Standard Error | log10 copies/mL | Baseline up to Week 48 and Week 96 |
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| Secondary | Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96 | Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF. | Posted | Mean | Standard Deviation | cells per microliter (cells/µL) | Baseline, Week 48, Week 96 |
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| Secondary | Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96 | Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. Change from baseline in lymphocyte CD8 count at Week 48 and 96 was not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF. | Posted | Mean | Standard Deviation | cells/µL | Baseline, Week 48, Week 96 |
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| Secondary | Time to Virologic Failure | Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU. | FAS population; Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. | Posted | Median | 95% Confidence Interval | days | Week 48, Week 96 |
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| Secondary | Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48 | Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure: discontinuation due to insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as last on treatment assessment. | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline. | Posted | Number | participants | Baseline, time of failure through Week 48 |
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| Secondary | Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96 | Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 96 visit. Treatment failure defined as insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as BLQ. The assessment for time of treatment failure was defined as last on treatment assessment. | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline. | Posted | Number | participants | Baseline, time of failure through Week 96 |
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| Secondary | Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96 | Phenotypic resistance to nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) assessed at screening by Monogram Bioscience PhenoSense genotype (MBPSGT) assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Phenotypic resistance to maraviroc was assumed in maraviroc treatment failures with X4-using virus and in R5 maraviroc treatment failures using Monogram Bioscience PhenoSense Entry Assay. Phenotypic resistance to zidovudine, lamivudine, efavirenz and maraviroc at time of failure was summarized. | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'n' is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response at specified time points for each arm group respectively. | Posted | Number | participants | Screening, time of failure through Week 48, Week 96 |
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| Secondary | Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96 | Genotypic resistance to NRTIs was assessed by identification of relevant mutations at screening using MBPSGT assay and repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure through week 48 and week 96. Following mutations associated with NRTIs were summarized at time of failure: Any zidovudine/lamivudine (Zid/Lam), Any thymidine analogue-associated mutation (TAM), methionine (M) to valine/isoleucine (V/I) substitution at residue (r) 184 (M184V/I), lysine (K) to arginine (R) substitution at residue 65 (K65R) and any other NRTI mutations. | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'n' is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response at specified time points for each arm group respectively. | Posted | Number | participants | Screening, time of failure through Week 48, Week 96 |
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| Secondary | Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96 | Genotypic resistance: mutations at screening by MBPSGT assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Efavirenz mutation:lysine to aspargine at r103(K103N);tyrosine to cysteine/isoleucine at r181(Y181C/I);tyrosine to cysteine/leucine/histidine at r188(Y188C/L/H);glycine to alanine/serine at r190(G190A/S);valine to alanine to r106(V106A);leucine to isoleucine at r100(L100I);alanine to glycine at r98(A98G);lysine to glutamic acid at r101(K101E);valine to isoleucine at r108(V108I);proline to histidine at r225(P225H);methionine to leucine at r230(M230L). | FAS population; n=participants with treatment failure at specified time points for each arm group respectively. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination focus shifted from efficacy, safety to only safety as reflected in abbreviated set of efficacy noted in amended planned analysis. | Posted | Number | participants | Screening, time of failure through Week 48, Week 96 |
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| Secondary | Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening | Association between baseline resistance and virological response was assessed as percentage of participants with HIV-1RNA levels less than 50 copies/mL by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. | Data not analyzed because of insufficient diversity amongst participants with respect to baseline resistance due to the study entry criteria regarding baseline resistance. | Posted | Baseline, Week 48, Week 96 |
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| Other Pre-specified | Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 96 | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F). | Posted | Number | Percentage of participants | Week 96 |
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| Post-Hoc | Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants | Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA. | FAS population; 'N' number of participants analyzed included ESTA R5 participants who had R5 tropic virus by ESTA at screening. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F). | Posted | Number | Percentage of participants | Week 48 |
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| Post-Hoc | Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants | Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA. | FAS population; 'N' number of participants analyzed included ESTA R5 participants who had R5 tropic virus by ESTA at screening. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F). | Posted | Number | Percentage of participants | Week 96 |
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Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL) | Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study. | 47 | 174 | 151 | 174 | ||
| EG001 | Maraviroc Twice Daily + CBV (DB and OL) | Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase. | 77 | 360 | 319 | 360 | ||
| EG002 | Efavirenz Once Daily + CBV (DB and OL) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase. | 82 | 361 | 327 | 361 | ||
| EG003 | Maraviroc Twice Daily + CBV (SP) | Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available. | 4 | 127 | 0 | 127 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Myocardial infarciton | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pulseless electrical activity | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Bicuspid aortic valve | Congenital, familial and genetic disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Haematotympanum | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Tinnitus | Congenital, familial and genetic disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Vertigo | Congenital, familial and genetic disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Diabetic eye disease | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Uveitis | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Anal fistula | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Rectal polyp | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Biliary colic | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hepatitis toxic | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Anaphylactic shock | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Anal fistula infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Anogenital warts | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Appendicitis perforated | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Cryptosporidiosis infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Disseminated tuberculosis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Hepatitis A | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Hepatitis C | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Intervertebral discitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Meningitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Meningitis bacterial | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Neurosyphilis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Orchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Parasitic gastroenteritis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Pelvic inflamatory disease | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Penile infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Peritoneal abscess | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Pneumocystis jiroveci infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Pneumonia staphylococcal | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Pulmonary tuberculosis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Sinobronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Staphylococcal bacteraemia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Subcutaneous abscess | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Syphilis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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| Chest injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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| Heart injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Human bite | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Multiple fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Whiplash injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gama-glutamytransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Castleman's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hoadgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nasopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vulval neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cranial nerve paralysis | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dyspraxia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Thoracic outlet syndrome | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vascular demetia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Drug dependence | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cervix haemorrhage uterine | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Uterine cervical laceration | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Penile ulceration | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Drug abuser | Social circumstances | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pregnancy of partner | Social circumstances | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
| |
| Finger amputation | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lipodystrophy acquired | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Following DSMB decision to discontinue maraviroc 300 mg once daily, inferential statistical analyses was performed between maraviroc 300 mg twice daily and efavirenz 600 mg once daily only. Data at Week 24 was not analyzed as planned in protocol.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| D015215 | Zidovudine |
| D019259 | Lamivudine |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
Not provided
Not provided
| Lack of Efficacy |
|
| Pregnancy |
|
| Protocol Violation |
|
| Participant Defaulted |
|
| Death |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| 18 to 24 years |
|
| 25 to 34 years |
|
| 35 to 44 years |
|
| 45 to 54 years |
|
| 55 to 64 years |
|
| Greater than or equal to 65 years |
|
| Male |
|
|
| Less than 50 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons. | Difference in Percentage | -4.2 | 1-Sided | 97.5 | -10.9 | Yes | Non-Inferiority or Equivalence | Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was > -10%. |
|
|
|
| OG002 | Efavirenz Once Daily + CBV (DB) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
|
|
|
| OG002 | Efavirenz Once Daily + CBV (DB) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
|
|
|
| Maraviroc Twice Daily + CBV (DB) |
Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
| OG002 | Efavirenz Once Daily + CBV (DB) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
|
|
|
|
|
|
Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
| OG002 | Efavirenz Once Daily + CBV (DB) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
|
|
|
|
|
|
|
|
|
| OG001 | Maraviroc Twice Daily + CBV (DB) | Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
| OG002 | Efavirenz Once Daily + CBV (DB) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
|
|
| OG001 | Maraviroc Twice Daily + CBV (DB) | Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
| OG002 | Efavirenz Once Daily + CBV (DB) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
|
|
| OG001 | Maraviroc Twice Daily + CBV (DB) | Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
| OG002 | Efavirenz Once Daily + CBV (DB) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
|
|
| OG001 | Maraviroc Twice Daily + CBV (DB) | Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
| OG002 | Efavirenz Once Daily + CBV (DB) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
|
|
Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
|
|
| OG001 | Maraviroc Twice Daily + CBV (DB) | Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
| OG002 | Efavirenz Once Daily + CBV (DB) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
|
| OG002 | Efavirenz Once Daily + CBV (DB) | Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. |
|
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|