Drug Interaction Study Between Dolutegravir and Prednisone
Public ClinicalTrials.gov record NCT01425099. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Adaptive, Two Part, Two Period, Single Sequence, Drug Interaction Study Between Dolutegravir 50 mg and Prednisone in Adult Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of human immunodeficiency virus (HIV) infection. DTG is primarily metabolized by UDP-glucuronosyltransferase (UGT1A1) with cytochrome P450 (CYP)3A4 pathway as a minor route. Corticosteroids have demonstrated induction effects on UGTs and CYP3A4. Corticosteroids are often used in HIV-infected subjects and have the potential to reduce DTG exposure due to enzyme induction when co-administered. The primary objective of this study is to determine whether concomitant prednisone administration can affect the pharmacokinetics (PK) of DTG. The study is a two part, two period, open label study. Part 1 will evaluate the effect of a high prednisone dose on DTG PK with the potential for an additional Part 2 depending on the results from Part 1. In Part 1, approximately 12 healthy subjects will receive DTG 50mg q24h for 5 days in Period 1. Subjects will then be administered DTG 50mg q24h in combination with prednisone 60mg for 5 days followed by a 5 day taper (total duration of 10 days) in Period 2. PK data of DTG will be obtained from Part 1 and used to inform decision making on the need for Part 2. If DTG exposure is reduced by more than 50% in Part 1, Part 2 will be carried out where a second cohort of subjects will receive DTG 50mg q24h DTG for 5 days in Period 1 followed by DTG 50mg q24h in combination with prednisone 20mg for 5 days followed by a 5 day taper (total duration of 10 days) in Period 2. Safety evaluations and serial PK samples for DTG will be collected during each treatment period. A follow-up visit will occur 7-14 days after the last dose of study drug. All doses of study drugs will be taken following a moderate fat meal. This study will be conducted at one center in the United States, with healthy adult male and female subjects.
Study identification
- NCT ID
- NCT01425099
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2011
- Primary completion
- Sep 30, 2011
- Completion
- Sep 30, 2011
- Last update posted
- Nov 6, 2011
2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Buffalo | New York | 14202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01425099, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 6, 2011 · Synced Sep 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01425099 live on ClinicalTrials.gov.