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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI068636 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Highly active antiretroviral therapy (HAART) has led to better health and survival rates among people with HIV/AIDS. The purpose of this study was to measure the effect of trained partner supervision when taking medication versus self-administered therapy in HIV infected participants. These participants have had their first virologic failure on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART regimen and were starting a protease inhibitor (PI)-based HAART regimen at study entry.
Poor adherence to HAART is usually associated with resistant virus. Poor adherence to HAART can have serious consequences, including limited treatment options for HIV infected individuals if they become infected with resistant HIV. The purpose of this study was to examine the effectiveness of modified directly observed therapy (mDOT) and compare it with the effectiveness of self-administered therapy (non-mDOT) in HIV infected individuals with first virologic failure on an NNRTI-based HAART regimen who were starting a PI-based HAART regimen at study entry.
mDOT was defined in this study as the daily observation of lopinavir/ritonavir (LPV/r) being taken on a regular basis. Observation consisted of an mDOT partner being present at the time the study participant took the observed dose. Half of the participants in this study were required to choose an mDOT partner to supervise adherence for the first 24 weeks of the study. Each mDOT partner completed the study-administered mDOT training program and was required to record all observed doses in an mDOT diary log. All participants and partners received health education through the study. Adherence was measured using Medication Event Monitoring System (MEMS) caps and self-report questionnaires.
This study lasted 52 weeks. Per protocol, participants were to be stratified according to their screening viral load and the proposed study treatment. The study treatment each participant received was based on their treatment history. At entry, participants were to start one of the two PI-based HAART regimens, either FTC/Tenofovir Disoproxil Fumarate (TDF) 200/300 mg once daily (QD) and Lopinavir/Ritonavir (LPV/RTV) 400/100 mg twice a day (BID) or TDF 300 mg QD and zidovudine (ZDV) 300 mg BID and LPV/RTV 400/100 mg BID. mDOT was used for the first 24 weeks of the study, followed by self-administration of study medications from week 25 to week 52. ZDV was not provided by the study. All enrolled participants except one who did not start study regimen initiated FTC/TDF and LPV/rtv after randomization. No participants started ZDV containing regimen on study. Thus, participants in this study were stratified by screening HIV-1 RNA only.
There were eight visits during the study. Medical and medication history, blood collection, and clinical assessment were required at all visits. A quality of life questionnaire and an adherence tools assessment were collected at most visits. For the mDOT arm, medication diary logs and mDOT partner monitoring were reviewed at most visits. An mDOT exit questionnaire and exit interview were required at the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mDOT arm | Experimental | Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks. |
|
| non-mDOT arm | Active Comparator | Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/ritonavir | Drug | Two tablets (200-mg lopinavir and 50 mg ritonavir in each tablet), taken orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Virologic Failure at or Prior to Week 48 | Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported. | At or prior to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Virologic Failure at or Prior to Week 24 | Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported. |
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Inclusion Criteria for Participants:
Inclusion Criteria for Partners:
Exclusion Criteria for Participants:
Exclusion Criteria for Partners:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Gross, MD, MSCE | University of Pennsylvania | Study Chair |
| Alberto La Rosa, MD | Asociación Civil Impacta Salud y Educación, Peru | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaborone Prevention/Treatment Trials CRS | Gaborone | Botswana | ||||
| Instituto de Pesquisa Clinica Evandro Chagas (12101) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17547827 | Background | Bangsberg DR, Kroetz DL, Deeks SG. Adherence-resistance relationships to combination HIV antiretroviral therapy. Curr HIV/AIDS Rep. 2007 May;4(2):65-72. doi: 10.1007/s11904-007-0010-0. | |
| 17525686 | Background | Conway B. The role of adherence to antiretroviral therapy in the management of HIV infection. J Acquir Immune Defic Syndr. 2007 Jun 1;45 Suppl 1:S14-8. doi: 10.1097/QAI.0b013e3180600766. |
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Five hundred twenty nine subjects including participants and partners entered the study. Among the 529 subjects, 259 were participants, which included two participants with eligibility violations. Only the 257 eligible participants were included in the analyses. All participants started TDF/FTC +LPV/rtv and stratified by screening HIV-1 RNA only.
Participants were recruited across 9 study sites (2 in Peru, one each in South Africa, Haiti, Uganda, Botswana, Zimbabwe, Brazil and Zambia) in the AIDS Clinical Trials Group system between April 2009 and September 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | mDOT Arm | Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks. |
| FG001 | Non-mDOT Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Emtricitabine/Tenofovir disoproxil fumarate | Drug | 200-mg emtricitabine and 300 mg tenofovir disoproxil fumarate in each tablet, taken orally once daily |
|
|
| Tenofovir disoproxil fumarate | Drug | 300-mg tablet taken orally once daily |
|
|
| Zidovudine | Drug | 300-mg tablet taken orally twice daily |
|
|
| Emtricitabine | Drug | 200-mg tablet taken orally once daily |
|
|
| At or prior to Week 24 |
| CD4 Count at Follow-up Visits | CD4 cell count (median, inter-quartile range) | At Weeks 4, 12, 24, 36, and 48 |
| CD8 Count at Follow-up Visits | CD8 cell count (median, inter-quartile range) | At week 4, 12, 24, 36, and 48 |
| Time to First Grade 3 or 4 Lab Event | 5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event | 52 weeks since randomization |
| Time to First Grade 3 or 4 Sign or Symptom | 5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom | 52 weeks since randomization |
| Time to First Grade 3 or 4 Lab or Sign/Symptom Event | 5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event | 52 weeks since randomization |
| Adherence to Second Line HAART Regimen | Number of participants with self-reported 100% adherence over the week prior to study visit | At weeks 4, 8, 12, 24, 36, 48 and 52 |
| Rio de Janeiro |
| 21045 |
| Brazil |
| Les Centres GHESKIO CRS | Bicentenaire | Port-au-Prince | HT-6110 | Haiti |
| San Miguel CRS | San Miguel | Lima region | Peru |
| Barranco CRS | Lima | 18 | Peru |
| Wits HIV CRS | Johannesburg | Gauteng | South Africa |
| JCRC CRS | Kampala | Uganda |
| Kalingalinga Clinic CRS | Lusaka | Zambia |
| UZ-Parirenyatwa CRS | Harare | Zimbabwe |
| 17639650 | Background | Goggin K, Liston RJ, Mitty JA. Modified directly observed therapy for antiretroviral therapy: a primer from the field. Public Health Rep. 2007 Jul-Aug;122(4):472-81. doi: 10.1177/003335490712200408. |
| 17693890 | Background | Pearson CR, Micek MA, Simoni JM, Hoff PD, Matediana E, Martin DP, Gloyd SS. Randomized control trial of peer-delivered, modified directly observed therapy for HAART in Mozambique. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):238-44. doi: 10.1097/QAI.0b013e318153f7ba. |
| 34788110 | Derived | Mantshonyane L, Roy J, Levy MZ, Wallis CL, Bar K, Godfrey C, Collier A, LaRosa A, Zheng L, Sun X, Gross R. Participants Switching to Second-Line Antiretroviral Therapy with Susceptible Virus Display Inferior Adherence and Worse Outcomes: An Observational Analysis. AIDS Patient Care STDS. 2021 Dec;35(12):467-473. doi: 10.1089/apc.2021.0115. Epub 2021 Nov 16. |
| 26774947 | Derived | De Boni RB, Zheng L, Rosenkranz SL, Sun X, Lavenberg J, Cardoso SW, Grinsztejn B, La Rosa A, Pierre S, Severe P, Cohn SE, Collier AC, Gross R. Binge drinking is associated with differences in weekday and weekend adherence in HIV-infected individuals. Drug Alcohol Depend. 2016 Feb 1;159:174-80. doi: 10.1016/j.drugalcdep.2015.12.013. Epub 2015 Dec 24. |
| 26424232 | Derived | Gross R, Zheng L, La Rosa A, Sun X, Rosenkranz SL, Cardoso SW, Ssali F, Camp R, Godfrey C, Cohn SE, Robbins GK, Chisada A, Wallis CL, Reynolds NR, Lu D, Safren SA, Hosey L, Severe P, Collier AC; ACTG 5234 team. Partner-based adherence intervention for second-line antiretroviral therapy (ACTG A5234): a multinational randomised trial. Lancet HIV. 2015 Jan;2(1):e12-9. doi: 10.1016/S2352-3018(14)00007-1. Epub 2014 Dec 11. |
Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Five hundred twenty nine subjects including participants and partners entered the study. Among the 529 subjects, 259 were participants, which include two participants with eligibility violations. Only the 257 eligible participants were included in the analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | mDOT Arm | Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks. |
| BG001 | Non-mDOT Arm | Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks. |
| 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 |
| ||||||||||||||||||
| CD4 Counts | The baseline CD4 count is the average of screening and entry values. | Median | Inter-Quartile Range | cells/mm3 |
| ||||||||||||||||
| CD4 Count Category | Number | participants |
| ||||||||||||||||||
| Log10 HIV-1 RNA Viral Load | The baseline HIV-1 RNA value is the result at study entry. | Median | Inter-Quartile Range | log10 copies/mL |
| ||||||||||||||||
| HIV-1 RNA Viral Load Category | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Confirmed Virologic Failure at or Prior to Week 48 | Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported. | Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed. | Posted | Number | participants | At or prior to Week 48 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Confirmed Virologic Failure at or Prior to Week 24 | Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported. | Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed. | Posted | Number | participants | At or prior to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CD4 Count at Follow-up Visits | CD4 cell count (median, inter-quartile range) | Posted | Median | Inter-Quartile Range | cells/mm3 | At Weeks 4, 12, 24, 36, and 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CD8 Count at Follow-up Visits | CD8 cell count (median, inter-quartile range) | Posted | Median | Inter-Quartile Range | cells/mm3 | At week 4, 12, 24, 36, and 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Grade 3 or 4 Lab Event | 5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event | Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed. | Posted | Number | 95% Confidence Interval | weeks | 52 weeks since randomization |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Grade 3 or 4 Sign or Symptom | 5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom | Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed. | Posted | Number | 95% Confidence Interval | weeks | 52 weeks since randomization |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Grade 3 or 4 Lab or Sign/Symptom Event | 5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event | Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed. | Posted | Number | 95% Confidence Interval | weeks | 52 weeks since randomization |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adherence to Second Line HAART Regimen | Number of participants with self-reported 100% adherence over the week prior to study visit | Only the 257 eligible participants were included in the analysis. Self-reported adherence was collected face-to-face or by self-report on the Adherence/Quality of Life/Psychosocial Interview form. Only adherence to LPV/rtv was collected. | Posted | Number | participants | At weeks 4, 8, 12, 24, 36, 48 and 52 |
|
|
52 weeks since randomization
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and ≥grade 3 AEs (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
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 | mDOT Arm | Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks. | 6 | 129 | 94 | 129 | ||
| EG001 | Non-mDOT Arm | Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks. | 7 | 128 | 98 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 16.0 | Systematic Assessment |
| |
| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 16.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood bicarbonate abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood cholesterol | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | 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 and Scientific Systems, Inc. | (301) 628-3313 | ACTGCT.Gov@s-3.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061466 | Lopinavir |
| C558899 | lopinavir-ritonavir drug combination |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068698 | Tenofovir |
| D015215 | Zidovudine |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| 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 |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Hispanic (regardless of race) |
|
| More than one race |
|
| Zambia |
|
| Botswana |
|
| Peru |
|
| Uganda |
|
| South Africa |
|
| Zimbabwe |
|
| Brazil |
|
| 51-100 cells/mm3 |
|
| 101-200 cells/mm3 |
|
| 201-350 cells/mm3 |
|
| 351-500 cells/mm3 |
|
| >500 cells/mm3 |
|
| 401-999 copies/mL |
|
| 1000-9999 copies/mL |
|
| 10000-99999 copies/mL |
|
| 100000-499999 copies/mL |
|
| >=500000 copies/mL |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|