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Evaluation of the Bioequivalence of a Combined Formulated Tablet
NCT01622790 · View on ClinicalTrials.gov ↗
Study Summary
Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations (FDCs) have greatly simplified the treatment of patients with HIV. While Atripla (an FDC of tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV)) has become the preferred first line regimen due in large part to its convenient presentation as a full treatment regimen in a single product, other options are needed. A fixed-dose combination of DTG/abacavir (ABC)/lamivudine (3TC) is one such opportunity. Part A of this study will be a single-dose, two-treatment crossover pivotal bioequivalence (BE) evaluation of the DTG/ABC/3TC FDC tablet in 66 healthy subjects. The reference formulations in this trial will be the 50 mg DTG tablet that is currently being used in the Phase 3 clinical trials and the already marketed FDC tablet product EPZICOM™ (ABC 600 mg/3TC 300 mg).It is intended that the results of this pivotal bioequivalence study will show that the proposed commercial DTG/ABC/3TC FDC tablet formulation is bioequivalent to DTG plus EPZICOM administered as separate tablets. Part B of this study will evaluate the effect of a high fat meal on the FDC tablet in 12 healthy subjects that have already participated in Part A of the study. There will be a screening visit within 30 days prior to the first dose of study drug and a follow up visit within 7-14 days after the last dose. There will be a 7 day washout between doses in each treatment period. The following PK parameters for DTG, ABC and 3TC will be measured: area under the concentration curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)), Area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration (AUC (0-t)), maximum observed concentration (Cmax), lag time before observation of drug concentrations (tlag), time of occurrence of Cmax (tmax), terminal phase h
Conditions Studied
Interventions
- DRUG Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg
- DRUG Dolutegravir 50 mg
- DRUG abacavir 600 mg/lamivudine 300 mg
Study Locations (1)
Kansas
- GSK Investigational Site — Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01622790
The ClinicalTrials.gov registry entry for NCT01622790 describes a study currently listed as completed. It is categorized as Phase 1, 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 66 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 Infection, Human Immunodeficiency Virus appearing as the primary indexed condition, and to 3 interventions — of which Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 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: NCT01622790 reports 1 study location spanning 1 distinct geographic area — top geographies include Kansas. 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 NCT01622790 about?
NCT01622790 is a clinical study titled "Evaluation of the Bioequivalence of a Combined Formulated Tablet". Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations (FDCs) have greatly simplified the treatment of patients with HIV. While Atripla (an FDC of tenofovir (TDF), emtricitabin...
What is the current status of trial NCT01622790?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2012-06. Estimated completion is 2012-08.
What conditions does trial NCT01622790 study?
This clinical trial studies the following conditions: 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 NCT01622790?
The interventions under investigation include: Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg (DRUG), Dolutegravir 50 mg (DRUG), abacavir 600 mg/lamivudine 300 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01622790?
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 NCT01622790 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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