Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001637-40 | EudraCT Number | ||
| MK-0518-284 | Other Identifier | Merck Protocol Number |
Not provided
Not provided
This study was terminated early due to poor recruitment.
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To evaluate changes in renal function, efficacy, and safety when switching from a combination of tenofovir/emtricitabine (TDF/FTC) plus a protease inhibitor/ritonavir (PI/r) to a combination of raltegravir (MK-0518) plus nevirapine plus lamivudine in human immunodeficiency virus (HIV)-1 infected participants with suppressed viremia and impaired renal function.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir plus Nevirapine plus Lamivudine | Experimental | Raltegravir 400 mg oral twice daily for 96 weeks; plus nevirapine 200 mg oral once daily for 14 days followed by nevirapine 200 mg oral twice daily, plus lamivudine 150 mg oral twice daily for 96 weeks |
|
| Protease Inhibitor/Ritonavir plus tenofovir/emtricitabine | Active Comparator | Tenofovir/emtricitabine 300/200 mg oral once daily plus 1) lopinavir/ritonavir 400/100 mg oral twice daily or 800/200 mg oral once daily, or 2) atazanavir/ritonavir 300/100 mg oral once daily, or 3) darunavir/ritonavir 800/100 mg oral once daily or 600/100 mg oral twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir (MK-0518) | Drug | Raltegravir (MK-0518) 400 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^-0.858 × [age]-0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^-0.293 × [urine urea nitrogen excretion (g/d)]^0.249. | Baseline and Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Suppressed Viremia (<50 Copies/mL HIV-1 Ribonucleic Acid [RNA]) at Week 48 | Plasma was to be collected at Week 48 in order to quantify HIV-1 RNA. and identify the percentage of participants with <50 copies/mL HIV-1 RNA. | Week 48 |
| Percentage of Participants With Suppressed Viremia (<50 Copies/mL HIV-1 RNA) at Week 96 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Human immunodeficiency virus (HIV) infected adults with stable suppressed HIV-1 ribonucleic acid (RNA) from at least 12 months prior to the screening visit, and with a current stable anti-retroviral (ARV) regimen were enrolled in this trial.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Raltegravir Plus Nevirapine Plus Lamivudine | Raltegravir 400 mg orally twice daily for 96 weeks; plus nevirapine 200 mg orally once daily for 14 days followed by nevirapine 200 mg orally twice daily, plus lamivudine 150 mg orally twice daily for 96 weeks |
| FG001 | Protease Inhibitor/Ritonavir Plus Tenofovir/Emtricitabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2015 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Nevirapine | Drug | Nevirapine (NVP) 200 mg tablets |
|
| Lamivudine | Drug | Lamivudine (3TC) 150 mg tablets |
|
| Tenofovir | Drug | Tenofovir disoproxil fumarate (TDF) 300 mg tablets |
|
| Emtricitabine | Drug | Emtricitabine (FTC) 200 mg tablets |
|
| Lopinavir | Drug | Lopinavir (LPV) 200 mg tablets |
|
| Ritonavir | Drug | Ritonavir (r) 100 mg tablets |
|
| Atazanavir | Drug | Atazanavir (ATV) 300 mg tablets |
|
| Darunavir | Drug | Darunavir (DAR) 400 mg tablets |
|
Plasma was to be collected at Week 96 in order to quantify HIV-1 RNA. and identify the percentage of participants with <50 copies/mL HIV-1 RNA. |
| Week 96 |
| Percentage of Participants With Decline in Renal Function at Week 48 | Decline in renal function was to be assessed by evaluating MDRD-6, creatinine clearance and serum phosphate. | Week 48 |
| Percentage of Participants With Virologic Failure (HIV-1 RNA > 50 Copies/mL) | Plasma was to be collected up to Week 96 in order to quantify HIV-1 RNA, and identify the percentage of participants with >50 copies/mL HIV-1 RNA. | Up to Week 96 |
| Change From Baseline of HIV-RNA Absolute Values | Plasma was to be collected at baseline and Week 96 in order to determine the change from baseline in HIV-1 RNA. | Baseline and Week 96 |
| Percentage of Participants With Mutations Associated With Resistance to NRTIs, NNRTIs, INI, at Virological Failure. | Participants were to be identified with mutations associated with Nucleoside/ Nucleotide Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Integrase Inhibitor (INI). Virological failure is defined as 2 consecutive plasma HIV-1 RNA >200 copies/mL at least two weeks apart while on previous or current ARV therapy. | Up to Week 96 |
| Change From Baseline in Absolute CD4+ T-lymphocyte Count | Cluster of Differentiation 4 + (CD4+) T-lymphocyte cell counts were to be determined at baseline and Week 96, in order to determine the change from baseline. | Baseline and Week 96 |
| Percentage of Participants With Altered Liver Enzymes and Lipid Profile | Values of liver enzymes and lipids were to be determined from laboratory tests, in order to identify the percentage of participants classified with altered values. | Up to Week 96 |
| Percentage of Participants With Altered Values of Tubular Kidney Injury Markers. | Values of tubular kidney injury markers. were to be determined, in order to identify the percentage of participants classified with altered values. | Up to Week 96 |
| Percentage of Participants Having Changes From Baseline in Metabolic Bone Markers | Changes from baseline in metabolic bone markers, serum Bone Specific Alkaline Phosphatase (s-BSAP) and C-telopeptides of type 1 Collagen (s-CTx), were to be determined, in order to classify the percentage of participants with changes. | Baseline and up to Week 96 |
| Area Under the Concentration Time Curve From Time 0 the Last Measurement Time t (AUC0-t) for Raltegravir and Nevirapine | Blood samples were to be collected in Week 12 in order to use the trapezoidal method to determine the AUC0-t of Raltegravir and Nevirapine | Week 12: Fasted state (0 h) and 1, 2, 3, 6 and 12 h post-dose |
| Trough Concentration (Ctrough) for Raltegravir and Nevirapine | Blood samples were to be collected in Weeks 12 and 48 in order to use the trapezoidal method to determine the Ctrough, the lowest concentration reached by the drug before the next dose is administered, of Raltegravir and Nevirapine. | Weeks 12 and 48: at the end of dosing interval at 12 h |
| Percentage of Participants With Genotypic Resistance at Virologic Failure. | Genotypic resistance measures the presence of particular HIV-1 mutations that give rise to drug resistance. Virological failure is defined as 2 consecutive plasma HIV-1 RNA >200 copies/mL at least two weeks apart while on previous or current ARV therapy. | Up to Week 96 |
| Percentage of Participants With Adherence to Study Therapy | An Adherence Questionnaire was to be given in order to determine the percentage of participants who adhered to study therapy. | Up to Week 96 |
| Change From Baseline in Bone Disease Risk Assessment | Bone disease risk assessment was to be based on a Fracture Risk Assessment Tool (FRAX®) score in participants > 40 years old, and the change from baseline determined. | Baseline and week 96 |
| Change From Baseline in the VACS Index | The Veterans Aging Cohort Risk Index (VACS Index) combines various clinical biomarkers into a cumulative index weighted according to the risk of all-cause mortality. | Baseline and week 96 |
| Percentage of Participants Experiencing a Decline of Renal Function | Decline in renal function was to be assessed by evaluating MDRD-6, creatinine clearance and serum phosphate. | Up to Week 96 |
| Change From Baseline in eGFR at Week 96 | Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^-0.858 × [age]-0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^-0.293 × [urine urea nitrogen excretion (g/d)]^0.249. | Baseline and Week 96 |
Tenofovir/emtricitabine 300/200 mg orally once daily plus 1) lopinavir/ritonavir 400/100 mg orally twice daily or 800/200 mg orally once daily, or 2) atazanavir/ritonavir 300/100 mg orally once daily, or 3) darunavir/ritonavir 800/100 mg orally once daily or 600/100 mg orally twice daily |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Raltegravir Plus Nevirapine Plus Lamivudine | Raltegravir 400 mg orally twice daily for 96 weeks; plus nevirapine 200 mg orally once daily for 14 days followed by nevirapine 200 mg orally twice daily, plus lamivudine 150 mg orally twice daily for 96 weeks |
| BG001 | Protease Inhibitor/Ritonavir Plus Tenofovir/Emtricitabine | Tenofovir/emtricitabine 300/200 mg orally once daily plus 1) lopinavir/ritonavir 400/100 mg orally twice daily or 800/200 mg orally once daily, or 2) atazanavir/ritonavir 300/100 mg orally once daily, or 3) darunavir/ritonavir 800/100 mg orally once daily or 600/100 mg 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, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Estimated Glomerular Filtration Rate (eGFR) | Estimated Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^-0.858 × [age]-0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^-0.293 × [urine urea nitrogen excretion (g/d)]^0.249. | Data for eGFR at baseline were not determined for 1 participant in each treatment group. | Mean | Standard Deviation | mL/min |
|
| 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 | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^-0.858 × [age]-0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^-0.293 × [urine urea nitrogen excretion (g/d)]^0.249. | All randomized participants who received at least one dose of study medications and who had both a baseline assessment, and at least one post-baseline assessment. | Posted | Mean | Standard Deviation | mL/min | Baseline and Week 48 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Suppressed Viremia (<50 Copies/mL HIV-1 Ribonucleic Acid [RNA]) at Week 48 | Plasma was to be collected at Week 48 in order to quantify HIV-1 RNA. and identify the percentage of participants with <50 copies/mL HIV-1 RNA. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Week 48 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Suppressed Viremia (<50 Copies/mL HIV-1 RNA) at Week 96 | Plasma was to be collected at Week 96 in order to quantify HIV-1 RNA. and identify the percentage of participants with <50 copies/mL HIV-1 RNA. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Week 96 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Decline in Renal Function at Week 48 | Decline in renal function was to be assessed by evaluating MDRD-6, creatinine clearance and serum phosphate. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Week 48 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure (HIV-1 RNA > 50 Copies/mL) | Plasma was to be collected up to Week 96 in order to quantify HIV-1 RNA, and identify the percentage of participants with >50 copies/mL HIV-1 RNA. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Up to Week 96 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline of HIV-RNA Absolute Values | Plasma was to be collected at baseline and Week 96 in order to determine the change from baseline in HIV-1 RNA. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Baseline and Week 96 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Mutations Associated With Resistance to NRTIs, NNRTIs, INI, at Virological Failure. | Participants were to be identified with mutations associated with Nucleoside/ Nucleotide Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Integrase Inhibitor (INI). Virological failure is defined as 2 consecutive plasma HIV-1 RNA >200 copies/mL at least two weeks apart while on previous or current ARV therapy. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Up to Week 96 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Absolute CD4+ T-lymphocyte Count | Cluster of Differentiation 4 + (CD4+) T-lymphocyte cell counts were to be determined at baseline and Week 96, in order to determine the change from baseline. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Baseline and Week 96 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Altered Liver Enzymes and Lipid Profile | Values of liver enzymes and lipids were to be determined from laboratory tests, in order to identify the percentage of participants classified with altered values. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Up to Week 96 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Altered Values of Tubular Kidney Injury Markers. | Values of tubular kidney injury markers. were to be determined, in order to identify the percentage of participants classified with altered values. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Up to Week 96 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Having Changes From Baseline in Metabolic Bone Markers | Changes from baseline in metabolic bone markers, serum Bone Specific Alkaline Phosphatase (s-BSAP) and C-telopeptides of type 1 Collagen (s-CTx), were to be determined, in order to classify the percentage of participants with changes. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Baseline and up to Week 96 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration Time Curve From Time 0 the Last Measurement Time t (AUC0-t) for Raltegravir and Nevirapine | Blood samples were to be collected in Week 12 in order to use the trapezoidal method to determine the AUC0-t of Raltegravir and Nevirapine | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Week 12: Fasted state (0 h) and 1, 2, 3, 6 and 12 h post-dose |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Trough Concentration (Ctrough) for Raltegravir and Nevirapine | Blood samples were to be collected in Weeks 12 and 48 in order to use the trapezoidal method to determine the Ctrough, the lowest concentration reached by the drug before the next dose is administered, of Raltegravir and Nevirapine. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Weeks 12 and 48: at the end of dosing interval at 12 h |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Genotypic Resistance at Virologic Failure. | Genotypic resistance measures the presence of particular HIV-1 mutations that give rise to drug resistance. Virological failure is defined as 2 consecutive plasma HIV-1 RNA >200 copies/mL at least two weeks apart while on previous or current ARV therapy. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Up to Week 96 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adherence to Study Therapy | An Adherence Questionnaire was to be given in order to determine the percentage of participants who adhered to study therapy. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Up to Week 96 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Bone Disease Risk Assessment | Bone disease risk assessment was to be based on a Fracture Risk Assessment Tool (FRAX®) score in participants > 40 years old, and the change from baseline determined. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Baseline and week 96 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the VACS Index | The Veterans Aging Cohort Risk Index (VACS Index) combines various clinical biomarkers into a cumulative index weighted according to the risk of all-cause mortality. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Baseline and week 96 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing a Decline of Renal Function | Decline in renal function was to be assessed by evaluating MDRD-6, creatinine clearance and serum phosphate. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Up to Week 96 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in eGFR at Week 96 | Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^-0.858 × [age]-0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^-0.293 × [urine urea nitrogen excretion (g/d)]^0.249. | Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed. | Posted | Baseline and Week 96 |
|
|
Up to Week 98
All randomized participants who received at least one dose of study treatment.
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 | Raltegravir Plus Nevirapine Plus Lamivudine | Raltegravir 400 mg orally twice daily for 96 weeks; plus nevirapine 200 mg orally once daily for 14 days followed by nevirapine 200 mg orally twice daily, plus lamivudine 150 mg orally twice daily for 96 weeks | 0 | 6 | 0 | 6 | 3 | 6 |
| EG001 | Protease Inhibitor/Ritonavir Plus Tenofovir/Emtricitabine | Tenofovir/emtricitabine 300/200 mg orally once daily plus 1) lopinavir/ritonavir 400/100 mg orally twice daily or 800/200 mg orally once daily, or 2) atazanavir/ritonavir 300/100 mg orally once daily, or 3) darunavir/ritonavir 800/100 mg orally once daily or 600/100 mg orally twice daily | 0 | 5 | 1 | 5 | 2 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President,Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Apr 5, 2019 |
| Prot_SAP_000.pdf |
| 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 |
|---|---|
| D000068898 | Raltegravir Potassium |
| D019829 | Nevirapine |
| D019259 | Lamivudine |
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| D000069446 | Atazanavir Sulfate |
| D000069454 | Darunavir |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011744 | Pyrimidinones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D005663 | Furans |
Not provided
Not provided
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
| Participants |
|
| Participants |
|
| Counts |
|---|
| Participants |
|