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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI068636 | U.S. NIH Grant/Contract | View source | |
| 5UM1AI068634 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The study was conducted on people who were taking their first anti-HIV drug regimen (including an Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), a type of anti-HIV drug) but the drugs in this regimen were not doing a good job of fighting their HIV infection.
The main purpose of this study was to compare two other anti-HIV drug regimens to see how well they fight HIV. The study also looked at how well participants tolerate the drug regimens and how safe they are.
The study was designed to determine whether taking the combination of lopinavir/ritonavir (LPV/r) plus raltegravir (RAL) works as well as what is usually used for second-line therapy: LPV/r plus the best-available nucleoside (nucleotide) reverse transcriptase inhibitor (NRTI) combination. Testing a regimen that does not include any NRTIs was important because NRTIs may no longer work for patients who received them as part of their first treatment regimen.
As more HIV-infected persons start antiretroviral therapy (ART) worldwide, the number needing second-line therapy is increasing. In many settings, an NNRTI-based regimen is the preferred first-line ART, whereas a protease inhibitor (PI)-based regimen is often reserved for second-line ART. Both of these types of regimens usually include two NRTIs.
As with initial ART, second-line regimens ideally should be composed of three fully active drugs that have potent anti-HIV activity to maximize the chances of durable viral suppression. However, such a goal may not be achieved with second-line PI-based regimens containing NRTIs because of resistance mutations from first-line therapy that reduce the activity of the NRTI class. The most significant of these mutations include M184V, thymidine analogue mutations (TAMs), Q151M complex, and K65R. The presence of K65R would result in resistance to most NRTIs (leaving only zidovudine (ZDV) and possibly abacavir (ABC) as active second-line options); the presence of multiple TAMs and/or Q151M alone or in complex with other mutations would also result in resistance to most NRTIs.
Recent data suggest that patients with isolated M184V-related NRTI resistance who subsequently switch to a boosted PI plus lamivudine (3TC)- or emtricitabine (FTC)-based regimen may achieve HIV-1 RNA suppression without the need to switch to more complex regimens [1]. Detection of an isolated M184V NRTI mutation is possible when resources allow for early diagnosis of virologic failure. However, in many resource-limited settings (RLS) early diagnosis of virologic failure is difficult because of infrequent monitoring of viral load or unavailability of viral load testing. This study intended to provide information applicable to the vast majority of RLS where resistance testing is not used routinely for selection of second-line regimens and PIs not needing refrigeration are preferred.
This was a phase III, dual-arm, open-label, randomized, non-inferiority study for participants who were on a failing NNRTI-containing first-line regimen. The study evaluated the difference in virologic failure rate between two treatment arms:
Arm A: LPV/r plus RAL Arm B: LPV/r plus best available NRTIs
Best available NRTI combinations were selected by the site investigator prior to randomization from a list of combinations approved by the study or in consultation with the A5273 Clinical Management Committee (CMC). The NRTIs provided by the study were FTC/TDF, ABC/3TC/ZDV, ABC/3TC, 3TC/ZDV, ABC, 3TC, and ZDV.
Participants took their assigned study therapy until 96 weeks of follow-up or 52 weeks after the last participant was enrolled (protocol amendment), whichever was earlier. This study originally planned to enroll 600 participants (300 per study arm), but the sample size was re-evaluated to 480 participants (240 per study arm), due to emergent data from other studies. Participants were assigned with equal probability to one of the two treatment regimens using permuted blocks. Randomization was stratified by three factors: screening HIV-1 RNA (≥100,000 versus <100,000 copies/mL); screening CD4+ cell count (≥100 versus <100 cells/mm3), and selection of ZDV in the NRTI regimen (yes/no). Furthermore, randomization was balanced by site.
During the study, participants were asked to return to the clinic at Weeks 4, 12, 24, and then every 12 weeks. Visits lasted about 30 minutes. At most visits, participants had a physical exam, had their arm, waist and hip circumference measured, and answered questions about their medical condition and any medications they were taking. At some visits, participants completed questionnaires to see how they were feeling, if they had been hospitalized recently, and how well they were taking their anti-HIV drugs, had their blood drawn and were asked to give urine samples. If the participant was female and able to become pregnant, a pregnancy test was taken at any visit that pregnancy was suspected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: LPV/r plus RAL | Experimental | Participants were administered LPV/r plus RAL orally twice daily throughout follow-up. |
|
| Arm B: LPV/r plus best available NRTIs | Experimental | Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs (listed below) throughout follow-up-
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/ritonavir | Drug | Lopinavir 400mg/ritonavir 100mg (given as two LPV 200mg/RTV 50mg fixed-dose combination tablets) orally twice daily, with or without food, throughout follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Probability of Virologic Failure by Week 48 | The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used. | From study entry to week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CD4+ Cell Count From Baseline to Week 48 | Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry. | Study entry and week 48 |
| Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto M La Rosa, MD | Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS | Study Chair |
| Ann C Collier, MD | Univ. of Washington Clinical HIV Research Program (CHIRP) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Pesquisa Clinica Evandro Chagas (12101) | Rio de Janeiro | 21045 | Brazil | |||
| BJ Medical College CRS (31441) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | [1] Hull M, Moore D, Harris M, et al. A lamivudine (3TC)-based backbone in conjunction with a boosted protease inhibitor (PI) is sufficient to achieve virologic suppression in the presence of M184V mutations. Program and abstracts of the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 12-15, 2009; San Francisco, California. Abstract H-916. | ||
| 33487029 | Derived | Torres TS, Harrison LJ, La Rosa AM, Zheng L, Cardoso SW, Ulaya G, Akoojee N, Kadam D, Collier AC, Hughes MD; for AIDS Clinical Trials Group (ACTG) A5273 Study Group. Poor quality of life and incomplete self-reported adherence predict second-line ART virological failure in resource-limited settings. AIDS Care. 2021 Oct;33(10):1340-1349. doi: 10.1080/09540121.2021.1874275. Epub 2021 Jan 23. | |
| 27240787 |
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515 were randomized 1:1 to treatment arms A and B.
Recruited at international AIDS Clinical Trials Group Units. Recruitment occurred between March 13, 2012 (date first participant was randomized) and October 2, 2013 (date last participant was randomized).
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: LPV/r Plus RAL | Participants were administered LPV/r plus RAL orally twice daily. Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Raltegravir: Raltegravir 400 mg tablet orally twice daily. |
| FG001 | Arm B: LPV/r Plus Best Available NRTIs |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Lopinavir/ritonavir | Drug | Lopinavir 400mg/ritonavir 100mg (given as three LPV 133.3 mg/RTV 33.3 mg fixed-dose combination soft gelatin capsules) orally twice daily, with food, throughout follow-up. |
|
|
| Raltegravir | Drug | Raltegravir 400 mg tablet orally twice daily, with or without food, throughout follow-up. |
|
|
| Emtricitabine/tenofovir disoproxil fumarate | Drug | Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily, with or without food, throughout follow-up. |
|
|
| Abacavir/lamivudine/zidovudine | Drug | Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily, with or without food, throughout follow-up. |
|
|
| Abacavir/lamivudine | Drug | Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily, with or without food, throughout follow-up. |
|
|
| Lamivudine/zidovudine | Drug | Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily, with or without food, throughout follow-up. |
|
|
| Abacavir | Drug | Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily, with or without food, throughout follow-up. |
|
|
| Zidovudine | Drug | Zidovudine 300 mg tablet orally twice daily, with or without food, throughout follow-up. |
|
|
| Lamivudine | Drug | Lamivudine 150 mg tablet orally twice daily, with or without food, throughout follow-up. |
|
|
Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline. |
| From study entry through to week 96 |
| Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline | The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. | From start of randomized treatment to off randomized treatment (up to 96 weeks) |
| Number of Participants Discontinuing Randomized Treatment for Toxicity | Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations. | From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks) |
| Number of Participants With a New AIDS-defining Events or Death | AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO) | From study entry throughout follow-up (up to 96 weeks) |
| Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death | Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes | From study entry throughout follow-up (up to 96 weeks) |
| Percentage of Time Spent in Hospital | The percentage of total study time that participants were in hospital. | From study entry throughout follow-up (up to 96 weeks) |
| Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline | Fasting was for 8 hours and the metabolic panel was drawn locally. | Study entry and week 48 |
| Pune |
| Maharashtra |
| 411001 |
| India |
| NARI Pune CRS | Pune | Maharashtra | India |
| Y.R.G Ctr, for AIDS Research and Education (11701) | Chennai | India |
| AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601) | Eldoret | 30100 | Kenya |
| College of Med. JHU CRS (30301) | Blantyre | Malawi |
| University of North Carolina Lilongwe CRS (12001) | Lilongwe | Malawi |
| San Miguel CRS | San Miguel | Lima region | Peru |
| Barranco CRS (11301) | Lima | 18 PE | Peru |
| Wits HIV CRS (11101) | Johannesburg | Gauteng | South Africa |
| Durban Adult HIV CRS (11201) | Durban | 4013 SF | South Africa |
| Soweto ACTG CRS (12301) | Johannesburg | South Africa |
| Univ. of Witwatersrand CRS (11101) | Johannesburg | South Africa |
| Kilimanjaro Christian Medical CRS | Kilimanjaro Region | Moshi | Tanzania |
| Chiang Mai University ACTG CRS (11501) | Chiang Mai | 50202 | Thailand |
| UZ-Parirenyatwa CRS (30313) | Harare | Zimbabwe |
| Derived |
| La Rosa AM, Harrison LJ, Taiwo B, Wallis CL, Zheng L, Kim P, Kumarasamy N, Hosseinipour MC, Jarocki B, Mellors JW, Collier AC; ACTG A5273 Study Group. Raltegravir in second-line antiretroviral therapy in resource-limited settings (SELECT): a randomised, phase 3, non-inferiority study. Lancet HIV. 2016 Jun;3(6):e247-58. doi: 10.1016/S2352-3018(16)30011-X. Epub 2016 Apr 18. |
Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs. Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily. Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily. Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily. Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily. Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily. Zidovudine: Zidovudine 300 mg tablet orally twice daily. Lamivudine: Lamivudine 150 mg tablet orally twice daily. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention to treat: All 512 participants without a major eligibility violation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: LPV/r Plus RAL | Participants were administered LPV/r plus RAL orally twice daily. Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Raltegravir: Raltegravir 400 mg tablet orally twice daily. |
| BG001 | Arm B: LPV/r Plus Best Available NRTIs | Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs. Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily. Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily. Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily. Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily. Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily. Zidovudine: Zidovudine 300 mg tablet orally twice daily. Lamivudine: Lamivudine 150 mg tablet orally twice daily. |
| BG002 | 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 |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| HIV-1 RNA | Mean | Standard Deviation | log10 copies/mL |
| |||||||||||||||||
| CD4+ T-cell count | Mean | Standard Deviation | cells/mm^3 |
|
| 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 | Cumulative Probability of Virologic Failure by Week 48 | The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used. | Intention to treat: All 512 participants without a major eligibility violation were included in the analysis: participants were analyzed per original assigned randomized treatment. | Posted | Number | 95% Confidence Interval | cumulative probability per 100 persons | From study entry to week 48 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4+ Cell Count From Baseline to Week 48 | Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry. | Intention to treat: All 488 participants without a major eligibility violation, and with baseline and week 48 data available were used in the analysis: participants were analyzed per original assigned randomized treatment. | Posted | Mean | 95% Confidence Interval | cells/mm^3 | Study entry and week 48 |
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| Secondary | Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure | Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline. | Participants with virologic failure, and with a pair of baseline and virologic failure sequences available, were included in the analysis. | Posted | Number | participants | From study entry through to week 96 |
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| Secondary | Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline | The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. | As treated: Participants on randomized treatment are included in this analysis. | Posted | Number | participants | From start of randomized treatment to off randomized treatment (up to 96 weeks) |
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| Secondary | Number of Participants Discontinuing Randomized Treatment for Toxicity | Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations. | Competing risk approach: Time was measured from start of randomized treatment until the date of randomized treatment discontinuation for toxicity. Randomized treatment discontinuation for other reasons was considered as an independent competing risk, and participants discontinuing the study were censored on the date of last participant contact. | Posted | Number | participants | From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks) |
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| Secondary | Number of Participants With a New AIDS-defining Events or Death | AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO) | Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment. | Posted | Number | participants | From study entry throughout follow-up (up to 96 weeks) |
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| Secondary | Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death | Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes | Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment. | Posted | Number | participants | From study entry throughout follow-up (up to 96 weeks) |
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| Secondary | Percentage of Time Spent in Hospital | The percentage of total study time that participants were in hospital. | Intention to treat: All 512 participants without a major eligibility violation were in the analysis: participants were analyzed per original assigned randomized treatment. | Posted | Number | percentage of time spent in hospital | From study entry throughout follow-up (up to 96 weeks) |
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| Secondary | Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline | Fasting was for 8 hours and the metabolic panel was drawn locally. | Intention to treat: All 512 participants without a major eligibility violation with data available at entry and week 48 were included in their assigned randomized treatment arm. total cholesterol (Arm A N=216 B N=220) HDL (Arm A N=219 B N=223) LDL (Arm A N=202 B N=205) triglycerides (Arm A N=219 B N=222), glucose (Arm A N=213 B N=223) | Posted | Mean | 95% Confidence Interval | mg/dL | Study entry and week 48 |
|
From study entry throughout follow-up (up to 96 weeks)
The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), version 2.0 January, 2010.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LPV/r + RAL | Participants were administered LPV/r plus RAL orally twice daily. Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Raltegravir: Raltegravir 400 mg tablet orally twice daily. | 19 | 258 | 252 | 258 | ||
| EG001 | LPV/r + NRTIs | Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs. Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily. Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily. Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily. Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily. Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily. Zidovudine: Zidovudine 300 mg tablet orally twice daily. Lamivudine: Lamivudine 150 mg tablet orally twice daily. | 30 | 254 | 250 | 254 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Toxic optic neuropathy | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| AIDS dementia complex | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Leptospirosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Meningitis cryptococcal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tuberculosis gastrointestinal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperlactacidaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood bicarbonate decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood calcium decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood glucose decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood phosphorus decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oropharyngeal plaque | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
Not provided
Not provided
| 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 |
|---|---|
| D061466 | Lopinavir |
| C558899 | lopinavir-ritonavir drug combination |
| D000068898 | Raltegravir Potassium |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C418262 | abacavir, lamivudine, and zidovudine drug combination |
| C492871 | abacavir, lamivudine drug combination |
| C109078 | lamivudine, zidovudine drug combination |
| C106538 | abacavir |
| D015215 | Zidovudine |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013936 | Thymidine |
| D015224 | Dideoxynucleosides |
| D016047 | Zalcitabine |
Not provided
Not provided
| >=65 years |
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| Male |
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| Black Non-Hispanic |
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| Hispanic (Regardless of Race) |
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| Asian, Pacific Islander |
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| South Africa |
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| India |
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| Zimbabwe |
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| Kenya |
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| Peru |
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| Brazil |
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| Tanzania |
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| Thailand |
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