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| ID | Type | Description | Link |
|---|---|---|---|
| 10395 | Registry Identifier | DAIDS ES | |
| ACTG A5241 | |||
| OPTIONS |
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| Name | Class |
|---|---|
| Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | NETWORK |
The goal of anti-HIV therapy is to prevent HIV from replicating. Long-term control of HIV requires at least two anti-HIV drugs that are active against the virus. Drug resistance is a problem for many treatment-experienced, HIV-infected people. The purpose of this study was to determine the benefit of adding a nucleoside reverse transcriptase inhibitor (NRTI) to a new anti-HIV drug regimen for the suppression of HIV.
Two or more fully active antiretrovirals (ARVs) are recommended for successful suppression of HIV. In people infected with resistant HIV virus, finding two drugs that are fully active against HIV can be a challenge. However, the new generation of anti-HIV drugs has been designed to suppress drug-resistant HIV. These drugs include the FDA-approved protease inhibitors (PIs) darunavir and tipranavir, the investigational non-nucleoside transcriptase inhibitor (nNRTI) etravirine, the FDA-approved fusion inhibitor enfuvirtide, the recently FDA-approved CCR5 inhibitor maraviroc, and the investigational integrase inhibitor raltegravir. Also, it is not yet known whether multiple, partially-active drugs have the same rate of success in suppressing HIV. The purpose of this study was to use HIV resistance testing to predict the potency of a suggested ARV regimen using second generation ARVs and determine if the benefits of adding NRTIs to this new drug regimen outweigh the risks of drug toxicity and pill burden. All participants had treatment experience or resistance to NRTIs, nNRTIs, and PIs, and received novel agents.
An active screening period (after enrollment but before randomization or treatment dispensation), occurred for up to 75 days for all participants, and study participation lasted an additional 96 weeks for those who qualified for either randomization or assignment (i.e. not randomized), to the study intervention. During active screening, all participants remained on their current drug regimen. During screening, phenotypic and genotypic HIV resistance tests were performed on participants' blood samples, as well as a coreceptor tropism assay. Using this information and medication history, the study team determined the best new regimen options for each participant. Each clinician, along with the study participant, then chose a new regimen based on the recommendations of the study team and the participant's preference.
Evaluation for study outcomes began when participants started their new regimen as assigned by either randomization or determined assignment. Stratification between Arms A (Add NRTIs) and B (Omit NRTIs) or Arm C (Non-randomized to Add NRTIs) was based on predicted activity of the new regimen. Those assigned to a regimen with higher predicted activity were randomly assigned to Arm A (Add NRTIs) or B (Omit NRTIs); those assigned a regimen predicted to have lower activity were not randomized, but were assigned to Arm C (Add NRTIs).
Participants in Arms A and C were instructed to take their newly assigned study regimen plus at least 2 NRTIs (personalized from expert recommendation and choice by local provider and participant) for 96 weeks. Participants in Arm B were instructed to take their newly assigned study regimen with no NRTIs for 96 weeks. Participants in all arms who met the primary efficacy outcome of regimen failure remained in the study in order to be followed for important secondary outcomes.
All participants were scheduled to have 13 clinical visits, which included blood collection. At some visits, urine collection and quality of life and adherence questionnaires occurred. A neurocognitive assessment was performed for all participants at time of starting the new study regimen. Participants may also have consented to have cerebrospinal fluid collected via lumbar puncture following study treatment assignment and/or at Week 24. Those participants who consented to cerebrospinal fluid collection also had neurocognitive assessments at the times of collections. Participants were responsible for obtaining certain ARVs not provided by the study, including the ARVs they during the active screening period.
The primary and secondary study objectives and comparisons relate to the randomized arms, and therefore, results are not provided for the non-randomized arm (C). The purpose of the non-randomized arm (C) was to include persons higher baseline resistance (and thus, lower activity scores) in order to address an exploratory objective related to the predictive power of these activity scores (and thus a larger range of scores by inclusion of arm C), on certain, virologic outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Regimen with higher predicted activity assigned by the study plus at least 2 NRTIs (personalized choice from expert recommendation) for 96 weeks. A 3-4 drug regimen was selected from the drugs listed to the right. |
|
| B | Experimental | Regimen with higher predicted activity assigned by the study without NRTIs for 96 weeks. A 3-4 drug regimen was selected from the drugs listed to the right. |
|
| C | Other | Regimen with lower predicted activity assigned plus at least 2 NRTIs (personalized choice from expert recommendation) for 96 weeks. A 3-4 drug regimen was selected from the drugs listed to the right. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enfuvirtide | Drug | 90mg subcutaneously twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Regimen Failure, Defined as a Confirmed Virologic Failure or Discontinuation of Randomized NRTI Component of Study Treatment | Virologic failure defined as confirmed plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for the discontinuation outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Results report percent of participants reaching regimen failure outcome by week 48 evaluation using Kaplan-Meier method. | From study entry to end of Week 48 evaluation window |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Treatment Dispensation to First Grade 3 or Higher (and at Least One Grade Higher Than Baseline) Signs/Symptom or Laboratory Abnormality | Events following permanent discontinuation of NRTI assignment are excluded (i.e. censoring at time of this event, if applicable). Week 96 study visit could occur up to 110 weeks following randomization. Censoring time was the latest study visit when participant was evaluated or when NRTI assignment was discontinued (when applicable). Event time was the exact number of weeks following treatment initiation when the qualifying sign/symptom started (for those safety events triggered by a sign/symptom), or exact number of weeks following treatment initiation when specimen from qualifying laboratory result was drawn (for those safety events triggered by a laboratory abnormality). |
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Inclusion Criteria:
Inclusion Criteria continued:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen T. Tashima, MD | Brown University | Study Chair |
| Richard H. Haubrich, MD | Division of Infectious Diseases, UCSD Antiviral Research Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Therapeutics CRS | Birmingham | Alabama | 35294-2050 | United States | ||
| Miller Children's Hosp. Long Beach CA NICHD CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17503659 | Background | Altmann A, Beerenwinkel N, Sing T, Savenkov I, Doumer M, Kaiser R, Rhee SY, Fessel WJ, Shafer RW, Lengauer T. Improved prediction of response to antiretroviral combination therapy using the genetic barrier to drug resistance. Antivir Ther. 2007;12(2):169-78. doi: 10.1177/135965350701200202. | |
| 17502727 | Background |
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A total of 104 exclusions among 517 enrolled to active screening but prior to assignment and dispensation of study treatment were due to any of the following: no resistance/tropism test results, not willing to accept any ARV study regimens, changes to current PI based ARV regimen or non-adherence, or changes with respect to eligibility criteria.
Subjects recruited between February 2008 and May 2011 from participating ACTG, IMPAACT, and ATN network sites located in the continental US and Puerto Rico.
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| ID | Title | Description |
|---|---|---|
| FG000 | Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) | [Arm A]Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Year of Follow-up |
|
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| Raltegravir |
| Drug |
400 mg twice daily |
|
| Darunavir | Drug | Two 300-mg tablets twice daily, given with ritonavir 100mg twice daily (ritonavir not provided by the study) |
|
| Tipranavir | Drug | Two 250-mg capsules twice daily, given with ritonavir 100mg twice daily (ritonavir not provided by the study) |
|
| Etravirine | Drug | Two 100-mg tablets twice daily |
|
| Maraviroc | Drug | Dosage dependent on regimen in which maraviroc is included |
|
| From treatment dispensation to week 96 study visit |
| Time From Treatment Dispensation to First Study ARV Modification (Excluding NRTIs, if Applicable) | First study ARV modification included any discontinuation or substitution of any chosen and initiated ARV for any reason. Events prompting study medication change could include protocol required (e.g. safety), protocol recommended but not required (e.g. virologic failure), or participant motivated (such as non-adherence, loss to follow-up or death; in other words, not protocol recommended or required). Event times were the exact weeks from treatment initiation to the time of qualifying regimen modification. Censoring times were the exact weeks from treatment initiation to the last date of study drugs. The week 96 (final study visit) could occur up through 110 weeks following randomization. | From treatment dispensation to week 96 study visit |
| Time From Randomization to Discontinuation of Randomized NRTI Component of Study Treatment | Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for meeting this outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Event times were scheduled study weeks when discontinuation events occurred. Censoring times were latest scheduled study visit weeks with evaluation. | From randomization to week 96 study visit |
| Time From Randomization to Confirmed Virological Failure | Virologic failure defined as confirmed (two consecutive) plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Event time was the scheduled study visit week when the initial plasma HIV-1 RNA specimen meeting the failure definition was collected. Censoring time was the latest scheduled study visit week when a plasma HIV-1 RNA specimen was collected and tested. | From randomization to week 96 study visit |
| Number of Participants With Plasma HIV-1 Viral Load < 50 Copies/ml | Number of participants with plasma HIV-1 Viral load < 50 copies/mL at study visit weeks 24, 48, and 96. Closest observed result between 20 and up to 30 weeks (for week 24), between 42 and up to 54 (for week 48), and between 90 and up to 110 (for week 96) used if multiple results available. Missing values excluded. | At Weeks 24, 48, 96 |
| Change in Plasma HIV-1 Viral Load From Baseline to Week 1 | Method of Kaplan and Meier used to accommodate left-censoring for those whose week 1 levels < 50 copies/mL. | From baseline to Week 1 evaluation |
| Change in Summarized Quality of Life Score | Quality-of-life score at each evaluation based upon a single question assessing participants' self-report of general health with a range of 0 (representing worst health status) to 100 (representing perfect health). | At study entry and Weeks 24, 48, 96 |
| Number of Participants Self-reporting Non-adherence to Assigned Study ARVS (Excluding NRTIs, if Applicable) | Results represent self-report of non-adherence during the 4-day period prior to the outcome evaluation visit. Participants in follow-up for whom these data are missing for any reason are inferred as not-adherent. | At Weeks 24 and 48 |
| Change in Cardiovascular Risk Score From Baseline | Cardiovascular risk score defined by Framingham providing an estimate of the probability of developing cardiovascular disease over the next 10-year period. Persons with a historical cardiovascular event (CAD, cerebro- or peripheral- vascular disorder, MI or stroke), were excluded, and scores were not calculated at follow-up times after individuals had a cardiovascular event. Missing values for input data (e.g. smoking status) resulted in a missing value for Framingham score. | At Weeks 24, 48, and 96 |
| Change in CD4 Count From Baseline | Baseline CD4 calculated as average of pre-entry and entry values. Closest observed result between 42 and up to 54 weeks (for week 48) or between 90 and up to 110 weeks (for week 96), used if multiple results available. Missing values excluded. | From study entry to Weeks 48 and 96 |
| Time From Treatment Dispensation to Serious Non-AIDS-defining Events | Serious Non-AIDS defining Events were adjudicated by independent and blinded review and possible events included serious diagnoses in the following disease areas: liver, cardiovascular, end-stage renal, non-AIDS malignancy, and diabetes mellitus. Week 96 study visit could take place up to 110 weeks following randomization. Event times were the exact weeks following treatment initiation corresponding to the diagnosis dates of the qualifying serious non-AIDS defining events. Censoring times were the weeks following treatment initiation corresponding to the latest study visit. | From treatment initiation to week 96 study visit |
| Number of Participants With Change in Virus Co-receptor Tropism Among Those With R5-only Tropic Virus at Study Entry | HIV Co-receptor tropism test result of either dual/mixed or evidence of X4 using virus from sample collected at confirmed virologic failure. | From study entry to time of confirmed virological failure (up to 96 weeks) |
| Change in Fasting Non-HDL Cholesterol From Baseline | Fasting non-HDL cholesterol calculated from difference between fasting total cholesterol and fasting HDL level. Missing values and non-fasting values excluded. | From study entry to Weeks 24, 48 |
| Participants With Newly Acquired HIV Drug Resistance Between Study Entry and Confirmed Virologic Failure | Defined among the subgroup of participants experiencing the outcome of confirmed virologic failure. Newly acquired HIV drug resistance is defined as one or more ARVs with partial resistance or resistance when pre-entry resistance was fully sensitive or resistant when pre-entry resistance was fully sensitive or partially sensitive. The ARVs included for resistance acquisition included the following: darunavir/ritonavir; etravirine, tipranavir, tenofovir, emtracitabine, lamivudine, zidovudine, abacavir. | Between baseline and confirmed virologic failure (up to 96 weeks) |
| Long Beach |
| California |
| 90806 |
| United States |
| University of Southern California CRS | Los Angeles | California | 90033 | United States |
| Usc La Nichd Crs | Los Angeles | California | 90033 | United States |
| UCLA CARE Center CRS | Los Angeles | California | 90035 | United States |
| UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | Los Angeles | California | 90095-1752 | United States |
| Stanford AIDS Clinical Trials Unit CRS | Palo Alto | California | 94304-5350 | United States |
| UCSD Antiviral Research Center CRS | San Diego | California | 92103 | United States |
| Ucsf Hiv/Aids Crs | San Francisco | California | 94110 | United States |
| Univ. of California San Francisco NICHD CRS | San Francisco | California | 94143 | United States |
| University of Colorado Hospital CRS | Aurora | Colorado | 80045 | United States |
| Denver Public Health CRS | Denver | Colorado | 80204 | United States |
| Georgetown University CRS (GU CRS) | Washington D.C. | District of Columbia | 20007 | United States |
| Children's National Med. Ctr. ATN CRS | Washington D.C. | District of Columbia | 20010 | United States |
| Howard Univ. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20060 | United States |
| Pediatric Perinatal HIV Clinical Trials Unit CRS | Miami | Florida | 33136 | United States |
| The Ponce de Leon Center CRS | Atlanta | Georgia | 30308-2012 | United States |
| Northwestern University CRS | Chicago | Illinois | 60611 | United States |
| Rush University CRS | Chicago | Illinois | 60612 | United States |
| Tulane Univ. New Orleans NICHD CRS | New Orleans | Louisiana | 70112-2699 | United States |
| IHV Baltimore Treatment CRS | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University CRS | Baltimore | Maryland | 21205 | United States |
| Massachusetts General Hospital CRS (MGH CRS) | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS | Boston | Massachusetts | 02115 | United States |
| Bmc Actg Crs | Boston | Massachusetts | 02118 | United States |
| Boston Medical Center Ped. HIV Program NICHD CRS | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02215 | United States |
| Wayne State Univ. CRS | Detroit | Michigan | 48201 | United States |
| Henry Ford Hosp. CRS | Detroit | Michigan | 48202 | United States |
| Washington University Therapeutics (WT) CRS | St Louis | Missouri | 63110 | United States |
| Cooper Univ. Hosp. CRS | Camden | New Jersey | 08103 | United States |
| New Jersey Medical School Clinical Research Center CRS | Newark | New Jersey | 07103 | United States |
| Rutgers - New Jersey Medical School CRS | Newark | New Jersey | 07103 | United States |
| Weill Cornell Chelsea CRS | New York | New York | 10011 | United States |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | United States |
| Nyu Ny Nichd Crs | New York | New York | 10016 | United States |
| Metropolitan Hosp. NICHD CRS | New York | New York | 10029 | United States |
| Columbia P&S CRS | New York | New York | 10032-3732 | United States |
| Columbia IMPAACT CRS | New York | New York | 10032 | United States |
| Harlem ACTG CRS | New York | New York | 10037 | United States |
| Trillium Health ACTG CRS | Rochester | New York | 14607 | United States |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | United States |
| Bronx-Lebanon Hosp. Ctr. CRS | The Bronx | New York | 10457 | United States |
| Chapel Hill CRS | Chapel Hill | North Carolina | 27514 | United States |
| Duke Univ. Med. Ctr. Adult CRS | Durham | North Carolina | 27710 | United States |
| Cincinnati CRS | Cincinnati | Ohio | 45267-0405 | United States |
| Case Clinical Research Site | Cleveland | Ohio | 44106 | United States |
| MetroHealth CRS | Cleveland | Ohio | 44109 | United States |
| Ohio State University CRS | Columbus | Ohio | 43210 | United States |
| The Research & Education Group-Portland CRS | Portland | Oregon | 97210 | United States |
| Penn Therapeutics, CRS | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson Univ. Med. Ctr. CRS | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh CRS | Pittsburgh | Pennsylvania | 15213-2582 | United States |
| The Miriam Hospital Clinical Research Site (TMH CRS) CRS | Providence | Rhode Island | 02906 | United States |
| St. Jude Children's Research Hospital CRS | Memphis | Tennessee | 38105 | United States |
| Vanderbilt Therapeutics (VT) CRS | Nashville | Tennessee | 37204 | United States |
| Trinity Health and Wellness Center CRS | Dallas | Texas | 75208 | United States |
| Houston AIDS Research Team CRS | Houston | Texas | 77030 | United States |
| Texas Children's Hospital CRS | Houston | Texas | 77030 | United States |
| Virginia Commonwealth Univ. Medical Ctr. CRS | Richmond | Virginia | 23298 | United States |
| University of Washington AIDS CRS | Seattle | Washington | 98104 | United States |
| Puerto Rico AIDS Clinical Trials Unit CRS | San Juan | 00935 | Puerto Rico |
| University of Puerto Rico Pediatric HIV/AIDS Research Program CRS | San Juan | 00935 | Puerto Rico |
| San Juan City Hosp. PR NICHD CRS | San Juan | 00936 | Puerto Rico |
| Eshleman SH, Husnik M, Hudelson S, Donnell D, Huang Y, Huang W, Hart S, Jackson B, Coates T, Chesney M, Koblin B. Antiretroviral drug resistance, HIV-1 tropism, and HIV-1 subtype among men who have sex with men with recent HIV-1 infection. AIDS. 2007 May 31;21(9):1165-74. doi: 10.1097/QAD.0b013e32810fd72e. |
| 17219736 | Background | Geretti AM. Clinical implications of HIV drug resistance to nucleoside and nucleotide reverse transcriptase inhibitors. AIDS Rev. 2006 Oct-Dec;8(4):210-20. |
| 17461850 | Background | Mallolas J, Blanco J, Labarga P, Vergara A, Ocampo A, Sarasa M, Arnedo M, Lopez-Pua Y, Garcia J, Juega J, Guelar A, Terron A, Dalmau D, Garcia I, Zarraga M, Martinez E, Carne X, Pumarola T, Escayola R, Gatell J. Inhibitory quotient as a prognostic factor of response to a salvage antiretroviral therapy containing ritonavir-boosted saquinavir. The CIVSA Study. HIV Med. 2007 May;8(4):226-33. doi: 10.1111/j.1468-1293.2007.00464.x. |
| 31135883 | Derived | Gandhi RT, Tashima KT, Smeaton LM, Vu V, Ritz J, Andrade A, Eron JJ, Hogg E, Fichtenbaum CJ. Long-term Outcomes in a Large Randomized Trial of HIV-1 Salvage Therapy: 96-Week Results of AIDS Clinical Trials Group A5241 (OPTIONS). J Infect Dis. 2020 Apr 7;221(9):1407-1415. doi: 10.1093/infdis/jiz281. |
| 26595748 | Derived | Tashima KT, Smeaton LM, Fichtenbaum CJ, Andrade A, Eron JJ, Gandhi RT, Johnson VA, Klingman KL, Ritz J, Hodder S, Santana JL, Wilkin T, Haubrich RH; A5241 Study Team. HIV Salvage Therapy Does Not Require Nucleoside Reverse Transcriptase Inhibitors: A Randomized, Controlled Trial. Ann Intern Med. 2015 Dec 15;163(12):908-17. doi: 10.7326/M15-0949. Epub 2015 Nov 24. |
| FG001 | Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2) | [Arm B] Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued. |
| FG002 | Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2 | [Non-randomized Group C] : Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 2nd Year of Follow-up |
|
|
Everyone randomized (ITT study sample), plus non-randomized group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) | Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started. |
| BG001 | Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2) | Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued. |
| BG002 | Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2 | Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| CD4 count, continuous | Mean | Standard Deviation | cells/mm^3 |
| |||||||||||||||
| Plasma HIV-1 RNA, continuous | Median | Inter-Quartile Range | log10 copies/mL |
|
| 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 | Percent of Participants With Regimen Failure, Defined as a Confirmed Virologic Failure or Discontinuation of Randomized NRTI Component of Study Treatment | Virologic failure defined as confirmed plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for the discontinuation outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Results report percent of participants reaching regimen failure outcome by week 48 evaluation using Kaplan-Meier method. | Analysis uses intent to treat population, among the two randomized arms only. | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to end of Week 48 evaluation window |
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| Secondary | Time From Treatment Dispensation to First Grade 3 or Higher (and at Least One Grade Higher Than Baseline) Signs/Symptom or Laboratory Abnormality | Events following permanent discontinuation of NRTI assignment are excluded (i.e. censoring at time of this event, if applicable). Week 96 study visit could occur up to 110 weeks following randomization. Censoring time was the latest study visit when participant was evaluated or when NRTI assignment was discontinued (when applicable). Event time was the exact number of weeks following treatment initiation when the qualifying sign/symptom started (for those safety events triggered by a sign/symptom), or exact number of weeks following treatment initiation when specimen from qualifying laboratory result was drawn (for those safety events triggered by a laboratory abnormality). | Only randomized participants included. Persons not starting study treatment excluded. | Posted | Number | 95% Confidence Interval | weeks | From treatment dispensation to week 96 study visit |
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| Secondary | Time From Treatment Dispensation to First Study ARV Modification (Excluding NRTIs, if Applicable) | First study ARV modification included any discontinuation or substitution of any chosen and initiated ARV for any reason. Events prompting study medication change could include protocol required (e.g. safety), protocol recommended but not required (e.g. virologic failure), or participant motivated (such as non-adherence, loss to follow-up or death; in other words, not protocol recommended or required). Event times were the exact weeks from treatment initiation to the time of qualifying regimen modification. Censoring times were the exact weeks from treatment initiation to the last date of study drugs. The week 96 (final study visit) could occur up through 110 weeks following randomization. | Only randomized participants included, and those who never started study treatment were excluded. | Posted | Number | 95% Confidence Interval | weeks | From treatment dispensation to week 96 study visit |
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| Secondary | Time From Randomization to Discontinuation of Randomized NRTI Component of Study Treatment | Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for meeting this outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Event times were scheduled study weeks when discontinuation events occurred. Censoring times were latest scheduled study visit weeks with evaluation. | All randomized participants included (i.e. ITT analysis). | Posted | Number | 95% Confidence Interval | weeks | From randomization to week 96 study visit |
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| Secondary | Time From Randomization to Confirmed Virological Failure | Virologic failure defined as confirmed (two consecutive) plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Event time was the scheduled study visit week when the initial plasma HIV-1 RNA specimen meeting the failure definition was collected. Censoring time was the latest scheduled study visit week when a plasma HIV-1 RNA specimen was collected and tested. | ITT (all randomized participants) included. | Posted | Number | 95% Confidence Interval | weeks | From randomization to week 96 study visit |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Plasma HIV-1 Viral Load < 50 Copies/ml | Number of participants with plasma HIV-1 Viral load < 50 copies/mL at study visit weeks 24, 48, and 96. Closest observed result between 20 and up to 30 weeks (for week 24), between 42 and up to 54 (for week 48), and between 90 and up to 110 (for week 96) used if multiple results available. Missing values excluded. | ITT - among 2 randomized arms only; closest value to scheduled week used if multiple values available; missing values excluded. Numbers analyzed at each time point represent those with a valid RNA result. | Posted | Number | participants | At Weeks 24, 48, 96 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Plasma HIV-1 Viral Load From Baseline to Week 1 | Method of Kaplan and Meier used to accommodate left-censoring for those whose week 1 levels < 50 copies/mL. | Modified intent to treat population among two randomized arms only: 2 participants (both in Omit NRTIs arm) were excluded because their baseline and week 1 RNA levels were both < 50 copies/mL. | Posted | Median | Inter-Quartile Range | log10 copies/mL | From baseline to Week 1 evaluation |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Summarized Quality of Life Score | Quality-of-life score at each evaluation based upon a single question assessing participants' self-report of general health with a range of 0 (representing worst health status) to 100 (representing perfect health). | Two randomized arms only. | Posted | Median | Inter-Quartile Range | units on a scale | At study entry and Weeks 24, 48, 96 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Self-reporting Non-adherence to Assigned Study ARVS (Excluding NRTIs, if Applicable) | Results represent self-report of non-adherence during the 4-day period prior to the outcome evaluation visit. Participants in follow-up for whom these data are missing for any reason are inferred as not-adherent. | Persons not starting study treatment, or not receiving assigned study treatment by randomization were excluded from all analyses. If person no longer in study follow-up before beginning of week 24 or 48 evaluation window, additionally excluded as applicable. | Posted | Number | participants | At Weeks 24 and 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Cardiovascular Risk Score From Baseline | Cardiovascular risk score defined by Framingham providing an estimate of the probability of developing cardiovascular disease over the next 10-year period. Persons with a historical cardiovascular event (CAD, cerebro- or peripheral- vascular disorder, MI or stroke), were excluded, and scores were not calculated at follow-up times after individuals had a cardiovascular event. Missing values for input data (e.g. smoking status) resulted in a missing value for Framingham score. | Persons not starting treatment (N=1; N=2), who had cardiovascular disease prior to study entry (N=12; N=8), or were missing input values needed to calculate a baseline Framingham score (N= 6; N=4), were excluded. | Posted | Mean | Standard Deviation | units on a scale | At Weeks 24, 48, and 96 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4 Count From Baseline | Baseline CD4 calculated as average of pre-entry and entry values. Closest observed result between 42 and up to 54 weeks (for week 48) or between 90 and up to 110 weeks (for week 96), used if multiple results available. Missing values excluded. | All subjects in the two randomized arms were assessed. | Posted | Median | Inter-Quartile Range | cells/mm^3 | From study entry to Weeks 48 and 96 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time From Treatment Dispensation to Serious Non-AIDS-defining Events | Serious Non-AIDS defining Events were adjudicated by independent and blinded review and possible events included serious diagnoses in the following disease areas: liver, cardiovascular, end-stage renal, non-AIDS malignancy, and diabetes mellitus. Week 96 study visit could take place up to 110 weeks following randomization. Event times were the exact weeks following treatment initiation corresponding to the diagnosis dates of the qualifying serious non-AIDS defining events. Censoring times were the weeks following treatment initiation corresponding to the latest study visit. | Randomized participants were included, and those not starting study treatment were excluded. | Posted | Number | 95% Confidence Interval | weeks | From treatment initiation to week 96 study visit |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Change in Virus Co-receptor Tropism Among Those With R5-only Tropic Virus at Study Entry | HIV Co-receptor tropism test result of either dual/mixed or evidence of X4 using virus from sample collected at confirmed virologic failure. | Only randomized participants with R5-tropic virus at study entry (N=89; N=88), and who experienced confirmed virologic failure (N=27; N=22) during follow-up, and who had a tropism test following failure are included. | Posted | Number | participants | From study entry to time of confirmed virological failure (up to 96 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Non-HDL Cholesterol From Baseline | Fasting non-HDL cholesterol calculated from difference between fasting total cholesterol and fasting HDL level. Missing values and non-fasting values excluded. | All randomized participants who started study treatment. Non-fasting results and missing results excluded from analysis. Therefore, differences reported here represent a complete case analysis. | Posted | Mean | Standard Deviation | mg/dL | From study entry to Weeks 24, 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Newly Acquired HIV Drug Resistance Between Study Entry and Confirmed Virologic Failure | Defined among the subgroup of participants experiencing the outcome of confirmed virologic failure. Newly acquired HIV drug resistance is defined as one or more ARVs with partial resistance or resistance when pre-entry resistance was fully sensitive or resistant when pre-entry resistance was fully sensitive or partially sensitive. The ARVs included for resistance acquisition included the following: darunavir/ritonavir; etravirine, tipranavir, tenofovir, emtracitabine, lamivudine, zidovudine, abacavir. | Those with confirmed virologic failure (N=54; N=50) among the randomized arms included; and those who were missing resistance information following virologic failure (N=2; N=4) are excluded. | Posted | Number | participants | Between baseline and confirmed virologic failure (up to 96 weeks) |
|
AE data collected between date of first dose of study Rx, and end of week 96 study visit window (up to 110 weeks post entry), which may include follow-up/events after PCD . Those who never started study Rx are excluded from AE evaluation and analysis.
Randomized arms only. All SAEs (per ICH, regardless of relationship to treatment), all cancers, MIs and hepatic failures; grade>2 signs/symptoms per ACTG criteria; all AST, ALT, creatinine, creatinine clearance, urinalysis, fasting lipid & glucose, and other Grade>2 labs, and all S/Sx or labs that lead to a change in study treatment were requested.
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 | Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) | Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started. | 58 | 180 | 169 | 180 | ||
| EG001 | Omit NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) | Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued. | 49 | 177 | 165 | 177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Autoimmune disorder | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Immune reconstitution inflammatory syndrome | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| AIDS dementia complex | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal wall infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Abscess of salivary gland | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Acute hepatitis B | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| HIV wasting syndrome | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes oesophagitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Meningitis listeria | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Mycobacterium avium complex infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Parvovirus infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Adenosquamous cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Testicular torsion | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Physical assault | Social circumstances | MedDRA 17.0 | Systematic Assessment |
| |
| Bartholin's cyst removal | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
| |
| Colostomy | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
| |
| Finger amputation | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
| |
| Inguinal hernia repair | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
| |
| Intervertebral disc operation | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood cholesterol | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood cholesterol abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood triglycerides | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Low density lipoprotein | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Low density lipoprotein abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
In accordance with the Clinical Trials 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 & 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 |
|---|---|
| D000077560 | Enfuvirtide |
| D000068898 | Raltegravir Potassium |
| D000069454 | Darunavir |
| C107201 | tipranavir |
| C451734 | etravirine |
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015700 | HIV Envelope Protein gp41 |
| D014760 | Viral Fusion Proteins |
| D050576 | Membrane Fusion Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D015488 | HIV Antigens |
| D000956 | Antigens, Viral |
| D014764 | Viral Proteins |
| D054299 | env Gene Products, Human Immunodeficiency Virus |
| D015686 | Gene Products, env |
| D012191 | Retroviridae Proteins |
| D054298 | Human Immunodeficiency Virus Proteins |
| D014759 | Viral Envelope Proteins |
| D015678 | Viral Structural Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014230 | Triazoles |
| D001393 | Azoles |
Not provided
Not provided
| Lost to Follow-up |
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| Clinic site closure |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
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|
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
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