Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI068636 | U.S. NIH Grant/Contract | View source | |
| PEARLS | |||
| A5185s | |||
| 5K24AI051966-03 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study compared 3 different three-drug combinations in HIV infected individuals starting their first HIV treatment regimens. Participants were recruited from resource-limited areas in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis was each of the once daily combinations (PI based, or NNRTI based) would not have inferior efficacy compared to the twice daily NNRTI based combination.
In developed countries, standard effective antiretroviral (ARV) therapy for treatment-naive HIV infected people includes three-drug combinations of two nucleoside reverse transcriptase inhibitors (NRTIs) with either a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI). However, direct comparisons of ARV efficacy in persons that more closely reflect the worldwide demographics of HIV-1 infection are needed.> > Trial participants were recruited in Africa (Malawi, South Africa, Zimbabwe), Asia (India, Thailand), South America (Brazil, Peru), Haiti, and the United States.>
> All participants were randomly assigned to one of three arms, and random allocation was stratified by 2 factors: country, and screening plasma HIV-1 RNA level (< 100,000 copies/mL versus >= 100,000 copies/mL). Participants assigned to the ZDV/3TC+EFV arm received lamivudine/zidovudine twice daily and efavirenz once daily. Participants assigned to the ddI+FTC+ATV arm received emtricitabine, atazanavir, and enteric-coated didanosine once daily. Participants assigned to the TDF/FTC+EFV arm received emtricitabine, tenofovir disoproxil fumarate, and efavirenz once daily. >
>
> Physical exam and blood collection occurred at entry and at most study visits. Participants experiencing virologic failure were offered a switch to another regimen. >
> On May 23, 2008, the ddI+FTC+ATV was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that this arm had significantly more virologic failure (and therefore was inferior when) compared to the ZDV/3TC+EFV arm . Participants still receiving ddI+FTC+ATV were offered alternative medications, and all participants continued to be followed. >
> On November 3, 2009, the DSMB recommended that the study close to all follow-up on May 31, 2010, before the designed termination (based on 30% of participants meeting the primary outcome) was met. The board observed that the recent accumulation of primary efficacy events (i.e. regimen failures) was very slow. Therefore, if the study were to continue another 1-2 years, the precision gained for treatment comparisons would likely be small.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZDV/3TC+EFV | Experimental | ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz |
|
| ddI+FTC+ATV | Experimental | ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine |
|
| TDF/FTC+EFV | Experimental | TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir | Drug | 400 mg taken orally daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure (PI Comparison) | Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). | Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008). |
| Time to Treatment Failure (NRTI Comparison) | Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). | Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) | Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). |
Not provided
Inclusion Criteria :>
Exclusion Criteria:>
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas B. Campbell, MD | University of Colorado, Denver | Study Chair |
| Timothy Flanigan, MD | The Miriam Hospital | Study Chair |
| James Hakim, MscClinEpi, FRCP | Department of Medicine, University of Zimbabwe | Study Chair |
| Nagalingeswaran Kumarasamy, MD | Centre for AIDS Research and Education | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033-1079 | United States | ||
| UCLA CARE Center CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16967040 | Background | Bartlett JA, Johnson J, Herrera G, Sosa N, Rodriguez A, Liao Q, Griffith S, Irlbeck D, Shaefer MS; Clinically Significant Long-Term Antiretroviral Sequential Sequencing Study (CLASS) Team. Long-term results of initial therapy with abacavir and Lamivudine combined with Efavirenz, Amprenavir/Ritonavir, or Stavudine. J Acquir Immune Defic Syndr. 2006 Nov 1;43(3):284-92. doi: 10.1097/01.qai.0000243092.40490.26. | |
| 15310939 | Background | Saag MS. Initiation of antiretroviral therapy: implications of recent findings. Top HIV Med. 2004 Jul-Aug;12(3):83-8. |
Not provided
Not provided
HIV-infected, treatment-naive men and women, at least 18 years of age with CD4+ count <300 cells/mm^3.
Study participants were recruited at 43 sites from 9 countries: 28 in the US, 4 in India, 2 each in Brazil, Malawi, Peru and South Africa, and 1 each in Haiti, Thailand and Zimbabwe, between May 2005 to August 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ZDV/3TC+EFV | ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz |
| FG001 | ddI+FTC+ATV | ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine > > On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| PI Comparison |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Didanosine (enteric-coated) | Drug | 400 mg taken orally daily |
|
|
| Efavirenz | Drug | 600 mg taken orally daily |
|
|
| Emtricitabine | Drug | 200 mg taken orally daily |
|
|
| Emtricitabine/Tenofovir disoproxil fumarate | Drug | 200 mg/300 mg taken orally once daily |
|
|
| Lamivudine/Zidovudine | Drug | 150 mg/300 mg taken orally twice daily |
|
|
| Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008) |
| Time to Immunologic Failure (PI Comparison) | Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. | At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008) |
| Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) | Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). | weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008) |
| Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) | Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. | Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008) |
| Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) | Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. | At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008) |
| Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) | Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. | Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) |
| Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) | Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. | Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) |
| Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) | Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). | Throughout follow-up until study closed (May 31,2010) |
| Time to Immunologic Failure (NRTI Comparison) | Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. | At or after Week 48 (including all follow-up through study closure - May 31,2010) |
| Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) | Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). | weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010) |
| Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) | Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. | At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010) |
| Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. | Week 48 (using follow-up through study closure on May 31,2010) |
| Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. | Week 96 (using follow-up through to study closure on May 31,2010) |
| Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. | Week 48 using follow-up through study closure on May 31,2010 |
| Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. | Week 96 using follow-up through study closure on May 31,2010 |
| Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) | Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. | Throughout study follow-up until study closure (May 31, 2010) |
| Los Angeles |
| California |
| 90095-1793 |
| United States |
| Harbor General/UCLA | Torrance | California | 90502-2052 | United States |
| Univ. of Colorado Health Sciences Center, Denver | Denver | Colorado | United States |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii | 96816-2396 | United States |
| Northwestern University | Chicago | Illinois | 60611-3015 | United States |
| Rush-Presbyterian/St. Lukes (Chicago) | Chicago | Illinois | 60612-3806 | United States |
| Cook County Hospital Core Center | Chicago | Illinois | 60612 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455-0392 | United States |
| Washington University (St. Louis) | St Louis | Missouri | 63108-2138 | United States |
| HIV Prevention & Treatment CRS | HVTN 722 West 168th Street MSPH Bldg. | New York | 10032 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| Cornell CRS | New York | New York | 10011 | United States |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | United States |
| Community Health Network, Inc. | Rochester | New York | 14642-0001 | United States |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642-0001 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Wake County Health and Human Services Clinical Research Site | Chapel Hill | North Carolina | 27514 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267-0405 | United States |
| The Ohio State Univ. AIDS CRS | Columbus | Ohio | 43210 | United States |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia | Pennsylvania | 19104 | United States |
| Stanley Street Treatment and Resource | Providence | Rhode Island | 02906 | United States |
| The Miriam Hosp. ACTG CRS | Providence | Rhode Island | 02906 | United States |
| Vanderbilt Therapeutics CRS | Nashville | Tennessee | 37204 | United States |
| University of Texas, Southwestern Medical Center | Dallas | Texas | United States |
| University of Texas, Galveston | Galveston | Texas | 77555-0435 | United States |
| Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS | Manguinhos | Rio de Janeiro | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Les Centres GHESKIO CRS | Bicentenaire | Port-au-Prince | HT-6110 | Haiti |
| YRG CARE Medical Ctr., VHS Chennai CRS | Rajiv Gandhi Salai Taramani | Chennai | 600113 | India |
| NARI Pune CRS | Pune | Maharashtra | India |
| NARI Clinic at NIV CRS | Maharashtra State | Pune | India |
| Dr. Kotnis Dispensary | Pune | 411026 | India |
| College of Med. JHU CRS | P.O. Box 1131 | Blantyre | Malawi |
| University of North Carolina Lilongwe CRS | Mzimba Road | Lilongwe | Malawi |
| Asociacion Civil Impacta Salud y Educacion - Miraf CRS | Barranco | Lima region | Peru |
| San Miguel CRS | San Miguel | Lima region | Peru |
| Wits HIV CRS | Johannesburg | Gauteng | 2092 | South Africa |
| Durban Adult HIV CRS | Durban | KwaZulu-Natal | 4001 | South Africa |
| Chiang Mai Univ. ACTG CRS | P.O. Box 80 | Chiang Mai | 50200 | Thailand |
| UZ-Parirenyatwa CRS | AIDS Research Unit P.O. Box A178 | Harare | Zimbabwe |
| 15857194 | Background | Tapper ML, Daar ES, Piliero PJ, Smith K, Steinhart C. Strategies for initiating combination antiretroviral therapy. AIDS Patient Care STDS. 2005 Apr;19(4):224-38. doi: 10.1089/apc.2005.19.224. |
| 34477118 | Derived | Gatechompol S, Zheng L, Bao Y, Avihingsanon A, Kerr SJ, Kumarasamy N, Hakim JG, Maldarelli F, Gorelick RJ, Welker JL, Lifson JD, Hosseinipour MC, Eron JJ, Ruxrungtham K. Prevalence and risk of residual viremia after ART in low- and middle-income countries: A cross-sectional study. Medicine (Baltimore). 2021 Sep 3;100(35):e26817. doi: 10.1097/MD.0000000000026817. |
| 25979186 | Derived | Firnhaber C, Smeaton LM, Grinsztejn B, Lalloo U, Faesen S, Samaneka W, Infante R, Rana A, Kumarasamy N, Hakim J, Campbell TB. Differences in antiretroviral safety and efficacy by sex in a multinational randomized clinical trial. HIV Clin Trials. 2015 May-Jun;16(3):89-99. doi: 10.1179/1528433614Z.0000000013. Epub 2015 May 15. |
| 25681380 | Derived | Kantor R, Smeaton L, Vardhanabhuti S, Hudelson SE, Wallis CL, Tripathy S, Morgado MG, Saravanan S, Balakrishnan P, Reitsma M, Hart S, Mellors JW, Halvas E, Grinsztejn B, Hosseinipour MC, Kumwenda J, La Rosa A, Lalloo UG, Lama JR, Rassool M, Santos BR, Supparatpinyo K, Hakim J, Flanigan T, Kumarasamy N, Campbell TB, Eshleman SH; AIDS Clinical Trials Group (ACTG) A5175 Study Team. Pretreatment HIV Drug Resistance and HIV-1 Subtype C Are Independently Associated With Virologic Failure: Results From the Multinational PEARLS (ACTG A5175) Clinical Trial. Clin Infect Dis. 2015 May 15;60(10):1541-9. doi: 10.1093/cid/civ102. Epub 2015 Feb 13. |
| 24979445 | Derived | Mollan KR, Smurzynski M, Eron JJ, Daar ES, Campbell TB, Sax PE, Gulick RM, Na L, O'Keefe L, Robertson KR, Tierney C. Association between efavirenz as initial therapy for HIV-1 infection and increased risk for suicidal ideation or attempted or completed suicide: an analysis of trial data. Ann Intern Med. 2014 Jul 1;161(1):1-10. doi: 10.7326/M14-0293. |
| 22936892 | Derived | Campbell TB, Smeaton LM, Kumarasamy N, Flanigan T, Klingman KL, Firnhaber C, Grinsztejn B, Hosseinipour MC, Kumwenda J, Lalloo U, Riviere C, Sanchez J, Melo M, Supparatpinyo K, Tripathy S, Martinez AI, Nair A, Walawander A, Moran L, Chen Y, Snowden W, Rooney JF, Uy J, Schooley RT, De Gruttola V, Hakim JG; PEARLS study team of the ACTG. Efficacy and safety of three antiretroviral regimens for initial treatment of HIV-1: a randomized clinical trial in diverse multinational settings. PLoS Med. 2012;9(8):e1001290. doi: 10.1371/journal.pmed.1001290. Epub 2012 Aug 14. |
| 22585772 | Derived | Nielsen-Saines K, Komarow L, Cu-Uvin S, Jourdain G, Klingman KL, Shapiro DE, Mofenson L, Moran L, Campbell TB, Hitti J, Fiscus S, Currier J; ACTG 5190/PACTG 1054 Study Team. Infant outcomes after maternal antiretroviral exposure in resource-limited settings. Pediatrics. 2012 Jun;129(6):e1525-32. doi: 10.1542/peds.2011-2340. Epub 2012 May 14. |
| 21499794 | Derived | Safren SA, Hendriksen ES, Smeaton L, Celentano DD, Hosseinipour MC, Barnett R, Guanira J, Flanigan T, Kumarasamy N, Klingman K, Campbell T. Quality of life among individuals with HIV starting antiretroviral therapy in diverse resource-limited areas of the world. AIDS Behav. 2012 Feb;16(2):266-77. doi: 10.1007/s10461-011-9947-5. |
| 20961784 | Derived | Firnhaber C, Smeaton L, Saukila N, Flanigan T, Gangakhedkar R, Kumwenda J, La Rosa A, Kumarasamy N, De Gruttola V, Hakim JG, Campbell TB. Comparisons of anemia, thrombocytopenia, and neutropenia at initiation of HIV antiretroviral therapy in Africa, Asia, and the Americas. Int J Infect Dis. 2010 Dec;14(12):e1088-92. doi: 10.1016/j.ijid.2010.08.002. Epub 2010 Oct 18. |
| FG002 | TDF/FTC+EFV | TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| NRTI Comparison |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ZDV/3TC+EFV | ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz |
| BG001 | ddI+FTC+ATV | ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine > > On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed. |
| BG002 | TDF/FTC+EFV | TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| CD4 count, Continuous | Screening value used for study eligibility as no other pre-randomization CD4 cell counts available | Mean | Standard Deviation | cells/mm^3 |
| ||||||||||||||
| CD4 count, Categorical | Screening CD4 count used for study eligibility as no other pre-randomization counts available. | Number | participants |
| |||||||||||||||
| Plasma HIV-1 RNA, Continuous | Median | Inter-Quartile Range | log10 copies/mL |
| |||||||||||||||
| Plasma HIV-1 RNA, Categorical | Number | participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Treatment Failure (PI Comparison) | Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). | ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured. | Posted | Number | 95% Confidence Interval | weeks | Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008). |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Time to Treatment Failure (NRTI Comparison) | Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). | ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured. | Posted | Number | 95% Confidence Interval | weeks | Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) | Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). | Participants not starting study treatment excluded. | Posted | Number | 95% Confidence Interval | weeks | Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Immunologic Failure (PI Comparison) | Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. | ITT (ignoring current study treatment status or history) | Posted | Number | 95% Confidence Interval | weeks | At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) | Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). | ITT - ignoring both current treatment status and treatment history. | Posted | Median | Inter-Quartile Range | cells/mm^3 | weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) | Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. | Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit. | Posted | Number | 95% Confidence Interval | weeks | Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) | Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. | ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored. | Posted | Number | participants | At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) | Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. | Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF. | Posted | Number | 95% Confidence Interval | weeks | Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) | Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. | Posted | Number | 95% Confidence Interval | weeks | Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) | Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). | Participants not starting study treatment excluded. | Posted | Number | 95% Confidence Interval | weeks | Throughout follow-up until study closed (May 31,2010) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Immunologic Failure (NRTI Comparison) | Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. | Posted | Number | 95% Confidence Interval | weeks | At or after Week 48 (including all follow-up through study closure - May 31,2010) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) | Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). | ITT - ignoring both current treatment status and treatment history. | Posted | Median | Inter-Quartile Range | cells/mm^3 | weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) | Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. | ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored. | Posted | Number | participants | At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. | Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF. | Posted | Number | 95% Confidence Interval | weeks | Week 48 (using follow-up through study closure on May 31,2010) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. | Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF. | Posted | Number | 95% Confidence Interval | weeks | Week 96 (using follow-up through to study closure on May 31,2010) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. | Posted | Number | 95% Confidence Interval | weeks | Week 48 using follow-up through study closure on May 31,2010 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. | Posted | Number | 95% Confidence Interval | weeks | Week 96 using follow-up through study closure on May 31,2010 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) | Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. | Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit. | Posted | Number | 95% Confidence Interval | weeks | Throughout study follow-up until study closure (May 31, 2010) |
|
Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study).
Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
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 | ZDV/3TC+EFV | 86 | 519 | 481 | 519 | |||
| EG001 | ddI+FTC+ATV | 84 | 526 | 521 | 526 | |||
| EG002 | TDF/FTC+EFV | 55 | 526 | 489 | 526 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bone marrow toxicity | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| AIDS related complex | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Abortion infected | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Chikungunya virus infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Corynebacterium sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Cryptococcosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Encephalitis viral | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| HIV infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Meningitis tuberculous | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cranial nerve paralysis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Monoplegia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Abortion spontaneous incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Blighted ovum | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dapsone syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood albumin abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood bicarbonate abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Decreased vibratory sense | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
In accordance with the Clinical Trial Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG ClinicalTrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems, Inc. | (301) 628-3313 | ACTGCT.Gov@s-3.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| 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 |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| D016049 | Didanosine |
| C098320 | efavirenz |
| D000068679 | Emtricitabine |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C109078 | lamivudine, zidovudine drug combination |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Withdrawal by Subject |
|
| Clinic site closed |
|
| Not reason above |
|
| Between 30 and 39 years |
|
| Between 40 and 49 years |
|
| At least 50 years |
|
| Male |
|
| Haiti |
|
| India |
|
| Malawi |
|
| Peru |
|
| South Africa |
|
| Thailand |
|
| United States |
|
| Zimbabwe |
|
| Between 50 and 99 cells/mm^3 |
|
| Between 100 and 199 cells/mm^3 |
|
| Between 200 and 249 cells/mm^3 |
|
| Between 250 and 299 cells/mm^3 |
|
| Between 400 and 4000 copies/mL |
|
| Between 4001 and 40,000 copies/mL |
|
| Between 40,001 and 400,000 copies/mL |
|
| Between 400,001 and 749,999 copies/mL |
|
| >= 750,000 copies/mL |
|
| Missing |
|
| 25th percentile |
|
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| TDF/FTC+EFV |
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|