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| Name | Class |
|---|---|
| Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann | UNKNOWN |
| Gilead Sciences | INDUSTRY |
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There is a critical need for safe and effective antiretroviral treatment (ART) regimens for HIV-2 infection. This is especially true in West Africa, where the vast majority of the 1-2 million individuals infected with HIV-2 live and were access to effective ART for HIV-2 is limited. HIV-2 is intrinsically resistant to non-nucleoside reverse transcriptase inhibitors (NNRTI) and the fusion inhibitor enfuvirtide (T-20) and mutations conferring broad resistance to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) are frequently observed in HIV-2 from patients receiving ART. Although antiretroviral protease inhibitors (PI) can be used effectively to treat HIV- 2, HIV-1 and HIV-2 also exhibit important differences in their susceptibilities with studies indicating that saquinavir (SQV), lopinavir (LPV), and darunavir (DRV) are the only potent PI's against HIV-2 replication and cross-resistance is frequent. Although an increasing body of evidence supports the potential utility of integrase inhibitors (INI) against HIV-2, there have been no clinical trials to assess their effectiveness and they are not routinely available in resource-limited settings. These limitations present major challenges to HIV-2 treatment, particularly in the areas in which it is most prevalent. This study is the 1st use of STRIBILD (elvitegravir (EVG), cobicistat (COBI), emtricitabine (FTC), tenofovir disoproxil fumarate (TDF)), an INI-based single tablet regimen, in HIV-2 infected adults in West Africa. The investigators hypothesize STRIBILD will be safe and effective as ART for HIV-2 infection. The Specific Aims of this study are: AIM 1: A pilot, open label, 48 week trial of STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) in 30 ARV-naïve HIV-2 Infected Adults in Dakar, Senegal. AIM 2: Determination of genotypic and phenotypic HIV-2 antiretroviral resistance in individuals with virologic failure (HIV-2 plasma RNA >250 copies/ml) participating in the 48 week trial of STRIBILD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label prospective single arm study of Stribild | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death | Number of Participants Experiencing Death within the study period | 48 weeks |
| New WHO Stage 3 or 4 Event | New AIDS defining event per WHO criteria | 48 weeks |
| Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml) | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3 or 4 Adverse Events | Adverse event per NIH/DAIDS criteria | 48 weeks |
| CD4 T-cell Count at 48 Weeks < Baseline | 48 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Interim 24 Weeks Analysis of Death | 24 weeks | |
| Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event | 24 weeks | |
| Interim Analysis at 24 Weeks of HIV-2 Virologic Failure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey S Gottlieb, MD PhD | University of Washington | Principal Investigator |
| Moussa Seydi, MD | Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann | Dakar | Senegal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29672676 | Derived | Ba S, Raugi DN, Smith RA, Sall F, Faye K, Hawes SE, Sow PS, Seydi M, Gottlieb GS; University of Washington-Dakar HIV-2 Study Group. A Trial of a Single-tablet Regimen of Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate for the Initial Treatment of Human Immunodeficiency Virus Type 2 Infection in a Resource-limited Setting: 48-Week Results From Senegal, West Africa. Clin Infect Dis. 2018 Oct 30;67(10):1588-1594. doi: 10.1093/cid/ciy324. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Prospective Single Arm Study of Stribild | Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Prospective Single Arm Study of Stribild | Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks |
| 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 |
| 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 | Death | Number of Participants Experiencing Death within the study period | Posted | Count of Participants | Participants | 48 weeks |
|
|
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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 | Open Label Prospective Single Arm Study of Stribild | Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CVA | Nervous system disorders | Systematic Assessment | stroke |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Geoffrey S Gottlieb. MD PhD (PI) | University of Washington | 1-206-616-2631 | gottlieb@uw.edu |
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| ID | Term |
|---|---|
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C509700 | elvitegravir |
| D000069547 | Cobicistat |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| < 50 CD4 T-cell Increase at 48 Weeks From Baseline |
| 48 weeks |
| Switching Off Stribild Prior to 48 Weeks | 48 Weeks |
| Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF | 48 weeks |
Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml) |
| 24 weeks |
| Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events | 24 weeks |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | New WHO Stage 3 or 4 Event | New AIDS defining event per WHO criteria | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
| Primary | Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml) | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
| Secondary | Grade 3 or 4 Adverse Events | Adverse event per NIH/DAIDS criteria | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
| Secondary | CD4 T-cell Count at 48 Weeks < Baseline | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
| Secondary | < 50 CD4 T-cell Increase at 48 Weeks From Baseline | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
| Secondary | Switching Off Stribild Prior to 48 Weeks | Posted | Count of Participants | Participants | 48 Weeks |
|
|
|
| Secondary | Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
| Other Pre-specified | Interim 24 Weeks Analysis of Death | Posted | Number | participants | 24 weeks |
|
|
|
| Other Pre-specified | Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Other Pre-specified | Interim Analysis at 24 Weeks of HIV-2 Virologic Failure | Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml) | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Other Pre-specified | Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| 1 |
| 30 |
| 0 |
| 30 |
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| D000068698 |
| Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| 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 |