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Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir
NCT01568892 · View on ClinicalTrials.gov ↗
Study Summary
Study ING116529 is a multicenter, randomized, study with an initial 7 day placebo- controlled, functional monotherapy phase to quantify the antiviral activity attributable to dolutegravir (DTG) in HIV-1 infected, ART-experienced adults who are experiencing virological failure on an Integrase inhibitor containing regimen (current RAL or ELV failures), with evidence of genotypic resistance to RAL or ELV at study entry. Thirty subjects will be randomized (1:1) to receive either DTG 50mg BID (Arm A) or Placebo (Arm B) with the current failing regimen for 7 days (RAL or ELV should be discontinued prior to dosing with DTG). At Day 8, subjects from both arms will enter an open label phase and receive open label DTG 50mg BID with an optimized background regimen containing at least one fully active drug.
Conditions Studied
Interventions
- DRUG Dolutegravir 50 mg twice daily
- DRUG Dolutegravir placebo twice daily
Study Locations (20)
California
- GSK Investigational Site — Bakersfield
- GSK Investigational Site — Beverly Hills
- GSK Investigational Site — Los Angeles
- GSK Investigational Site — San Diego
New York
- GSK Investigational Site — Buffalo
- GSK Investigational Site — New York
- GSK Investigational Site — The Bronx
- GSK Investigational Site — Valhalla
Florida
- GSK Investigational Site — Fort Lauderdale
- GSK Investigational Site — Ft. Pierce
- GSK Investigational Site — Orlando
District of Columbia
- GSK Investigational Site — Washington D.C.
- GSK Investigational Site — Washington D.C.
Georgia
- GSK Investigational Site — Augusta
- GSK Investigational Site — Savannah
Arkansas
- GSK Investigational Site — Little Rock
Connecticut
- GSK Investigational Site — Norwalk
Illinois
- GSK Investigational Site — Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-04-18 |
| Est. Completion | 2013-12-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01568892
The ClinicalTrials.gov registry entry for NCT01568892 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 30 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 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions — of which Dolutegravir 50 mg twice daily 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: NCT01568892 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, New York, Florida. 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 NCT01568892 about?
NCT01568892 is a clinical study titled "Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir". Study ING116529 is a multicenter, randomized, study with an initial 7 day placebo- controlled, functional monotherapy phase to quantify the antiviral activity attributable to dolutegravir (DTG) in HIV-1 infected, ART-experienced adults who are experiencing virological failure on an Integrase inhibit...
What is the current status of trial NCT01568892?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2012-04-18. Estimated completion is 2013-12-16.
What conditions does trial NCT01568892 study?
This clinical trial studies the following conditions: HIV Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01568892?
The interventions under investigation include: Dolutegravir 50 mg twice daily (DRUG), Dolutegravir placebo twice daily (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01568892?
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 NCT01568892 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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