Trials / Completed
CompletedNCT00002372
A Study of 141W94 in Combination With Other Anti-HIV Drugs
A Phase I/II Screening Trial to Identify Potential Partner Compounds to Use in Combination With 141W94
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (planned)
- Sponsor
- Glaxo Wellcome · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To determine the steady-state pharmacokinetics of 141W94 in combination with saquinavir, indinavir and nelfinavir after multiple oral dosing. To determine the steady-state pharmacokinetics of saquinavir, indinavir, and nelfinavir in combination with 141W94 after multiple oral dosing. To assess the safety and tolerability of multiple doses of 141W94 when combined with saquinavir, indinavir and nelfinavir.
Detailed description
Patients will be randomized to receive open label 141W94 in combination with saquinavir, indinavir and nelfinavir. The randomized phase will be preceded by a single dose pharmacokinetic interaction study of 141W94 and indinavir in 12 patients. Data from this single dose investigation will be used to determine the dose of indinavir to be used in the randomized phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Indinavir sulfate | |
| DRUG | Amprenavir | |
| DRUG | Nelfinavir mesylate | |
| DRUG | Saquinavir |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00002372. Inclusion in this directory is not an endorsement.