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Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine
NCT01641809 · View on ClinicalTrials.gov ↗
Study Summary
The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral activity and tolerability in HIV-1 infected, antiretroviral naive subjects. This study consists of two parts: Induction Phase: Approximately 200 subjects will be randomized (50 subjects in each of the 4 treatment arms). The Induction Phase consists of a 24 week dose-ranging evaluation of GSK1265744 at blinded doses of 10 mg, 30 mg and 60 mg once-daily and a control arm of open-label efavirenz (EFV) 600 mg once daily. The background dual nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral therapy (ART) for all arms will be either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) as selected by the Investigator. Subjects randomized to a GSK1265744 containing arm, who successfully complete 24 weeks on study and demonstrate virologic suppression (defined as having a plasma HIV-1 ribonucleic acid \[RNA\] \<50 copies per milliliter \[c/mL\] before Week 24, with no signs of virologic rebound) will become eligible for the Maintenance Phase of this study. Maintenance Phase: The background NRTIs will be discontinued and the subjects will continue their randomized dose of GSK1265744 in combination with rilpivirine (RPV) 25 mg once-daily for an additional 72 weeks. The Maintenance phase will evaluate the ability of this two drug ART regimen to maintain virologic suppression through Week 48, Week 72 and Week 96. Subjects randomized to the EFV arm will continue on their randomized regimen through Week 96. After completion of the maintenance phase, subjects could enroll in the Open-Label Phase to continue GSK1265744 + RPV treatment as long as they continue to derive clinical benefit and until it is locally approved and commercially available.
Conditions Studied
Interventions
- DRUG GSK1265744 10 mg
- DRUG GSK1265744 30 mg
- DRUG GSK1265744 60 mg
- DRUG Efavirenz 600 mg
- DRUG Rilpivirine 25 mg
Study Locations (20)
Florida
- GSK Investigational Site — Fort Lauderdale
- GSK Investigational Site — Fort Lauderdale
- GSK Investigational Site — Ft. Pierce
- GSK Investigational Site — Miami
- GSK Investigational Site — Oakland Park
- GSK Investigational Site — Orlando
- GSK Investigational Site — West Palm Beach
California
- GSK Investigational Site — Bakersfield
- GSK Investigational Site — Beverly Hills
- GSK Investigational Site — Long Beach
- GSK Investigational Site — Los Angeles
- GSK Investigational Site — San Francisco
District of Columbia
- GSK Investigational Site — Washington D.C.
- GSK Investigational Site — Washington D.C.
Georgia
- GSK Investigational Site — Atlanta
- GSK Investigational Site — Augusta
Alabama
- GSK Investigational Site — Birmingham
Arizona
- GSK Investigational Site — Phoenix
Arkansas
- GSK Investigational Site — Little Rock
Colorado
- GSK Investigational Site — Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2012-08-06 |
| Est. Completion | 2019-01-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01641809
The ClinicalTrials.gov registry entry for NCT01641809 describes a study currently listed as completed. It is categorized as Phase 2, 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 244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 5 interventions — of which GSK1265744 10 mg 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: NCT01641809 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, District of Columbia. 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 NCT01641809 about?
NCT01641809 is a clinical study titled "Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine". The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral activity and tolerability in HIV-1 infected, antiretroviral naive subjects. This study consists of two parts: Induction Phase: Approximately 200 subjects will be randomized (50 subjects in each of the 4 treatm...
What is the current status of trial NCT01641809?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 244 participants. The study started on 2012-08-06. Estimated completion is 2019-01-15.
What conditions does trial NCT01641809 study?
This clinical trial studies the following conditions: HIV Infections, Infection, Human Immunodeficiency Virus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01641809?
The interventions under investigation include: GSK1265744 10 mg (DRUG), GSK1265744 30 mg (DRUG), GSK1265744 60 mg (DRUG), Efavirenz 600 mg (DRUG), Rilpivirine 25 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01641809?
This trial is sponsored by ViiV Healthcare, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01641809 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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