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Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
NCT01967940 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen. There are 2 parts to this study: Part 1 and Part 2. Part 1 consists of 2 cohorts, starting with a sentinel cohort, in which participants will be enrolled to receive open-label TAF in addition to their current failing ARV regimen. This cohort will then be followed by a randomized, double-blind, cohort to compare the addition of TAF or placebo in HIV-1 positive adults who are failing their current ARV regimen. In Part 2, all participants who complete Part 1 of the study will discontinue their failing ARV regimen and TAF or placebo for a 14-day washout period. Following the washout period, all participants who received TAF in Part 1 and have a \> 0.5 log10 decline in HIV-1 RNA will receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) plus atazanavir (ATV) once daily for 48 weeks. Participants who received TAF who have a ≤ 0.5 log10 decline in HIV-1 RNA will be discontinued from the study and will not be eligible to continue into Part 2 of the study. All participants who received placebo in Part 1 will be eligible to participate in Part 2 regardless of their viral load change. After completion of Part 2, all participants will be eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF becomes commercially available, or until Gilead Sciences terminates development of E/C/F/TAF in the applicable country.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TAF
- DRUG ATV
- DRUG E/C/F/TAF
- DRUG Current failing ARV regimen
Study Locations (15)
Other
- Salvador B Gautier Hospital - Infectious Diseases Department — Santo Domingo
- Instituto Dominicano de Estudio Virologicos - IDEV — Santo Domingo
- Regional state budget health agency Krasnoyarsk Regional Center for Prevention and Control of AIDS — Krasnoyarsk
- Center For Prevention and Treatment of AIDS and Infectious Diseases, Saint Petersburg — Saint Petersburg
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) — Bangkok
- Ramathibodi Hospital, Mahidol University — Bangkok
- Siriraj Hospital Department of Preventive and Social Medicine, Faculty of Medicine — Bangkok
- Chiang Mai University — Chiang Mai
- Khon Kaen University — Khon Kaen
- Joint Clinical Research Centre — Kampala
Florida
- Midway Immunology and Research center — Ft. Pierce
- Triple O Research Institute, P.A. — West Palm Beach
- Rowan Tree Medical, P.A. — Wilton Manors
North Carolina
- Wake Forest University Health Sciences — Winston-Salem
Pennsylvania
- Penn Presbyterian Medical Center — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2013-10-25 |
| Est. Completion | 2017-07-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01967940
The ClinicalTrials.gov registry entry for NCT01967940 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with HIV Infections appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01967940 reports 15 study locations spanning 4 distinct geographic areas — top geographies include Other, Florida, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01967940 about?
NCT01967940 is a clinical study titled "Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults". The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen. There are 2 parts to this study: Part 1 and Part 2. Part 1 consists of 2 cohorts, starting with a sentinel cohort...
What is the current status of trial NCT01967940?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2013-10-25. Estimated completion is 2017-07-31.
What conditions does trial NCT01967940 study?
This clinical trial studies the following conditions: HIV Infections, HIV, Acquired Immunodeficiency Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01967940?
The interventions under investigation include: Placebo (DRUG), TAF (DRUG), ATV (DRUG), E/C/F/TAF (DRUG), Current failing ARV regimen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01967940?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01967940 being conducted?
This trial has 15 study locations across Florida, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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