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NCT02738931 · ClinicalTrials.gov registry record · Phase 1
Relative Bio-availability Study of Dolutegravir and Lamivudine Fixed Dose Combinations
A Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT02738931: Completed Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
NCT02738931 is a Phase 1 study of Infection, Human Immunodeficiency Virus that has completed, run by ViiV Healthcare. The registered enrollment target is 30 participants, below the 146-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02738931, a Phase 1 study of Infection, Human Immunodeficiency Virus, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Dolutegravir (DTG) and lamivudine (3TC) are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Fixed dose combination (FDC) tablets of existing approved drugs are preferred by many patients and offer the potential for increased patient adherence and consequently a reduced likelihood of virological failure and viral resistance. The purpose of the present study is to evaluate the relative bioavailability of two experimental FDC tablets of DTG and 3TC relative to co-administration of the single entity products in healthy adult subjects. This study will be conducted as a randomized, open label three-way, crossover design with 6 treatment sequences in approximately 30 subjects. Each subject will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods each with a single dose of study drug and a follow-up visit within 7-14 days after the last dose of study drug. There will be at least 7 days washout between dosing periods. The total duration of participation of a subject in this study will be approximately 9 weeks.
Primary Outcome
Serial blood samples for pharmacokinetic (PK) analysis of DTG will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Conditions Studied
Interventions
- DRUG Dolutegravir 50 mg tablet
- DRUG Lamivudine 300 mg tablet
- DRUG Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA)
- DRUG Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)
Study Locations (1)
Kansas
- GSK Investigational Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-05 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02738931 record still lists
NCT02738931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 146-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Infection, Human Immunodeficiency Virus appearing as the primary indexed condition, and to 4 interventions - of which Dolutegravir 50 mg tablet is the first listed.
NCT02738931 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT02738931 about?
NCT02738931 is a clinical study titled "Relative Bio-availability Study of Dolutegravir and Lamivudine Fixed Dose Combinations". Dolutegravir (DTG) and lamivudine (3TC) are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Fixed dose combination (FDC) tablets of existing approved drugs are preferred by many patients and offer the potential for...
What is the current status of trial NCT02738931?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2016-05. Estimated completion is 2016-06.
What conditions does trial NCT02738931 study?
This clinical trial studies the following conditions: Infection, Human Immunodeficiency Virus.
What interventions are being tested in trial NCT02738931?
The interventions under investigation include: Dolutegravir 50 mg tablet (DRUG), Lamivudine 300 mg tablet (DRUG), Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA) (DRUG), Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB) (DRUG).
Who is sponsoring clinical trial NCT02738931?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02738931 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02738931's enrollment target sits among peer trials
30 13th of 19 higher than 7 of 19 other Infection, Human Immunodeficiency Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infection, Human Immunodeficiency Virus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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