A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC
Public ClinicalTrials.gov record NCT00002208. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.
Study identification
- NCT ID
- NCT00002208
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Jun 23, 2005
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama at Birmingham | Birmingham | Alabama | 352942050 | — |
| LAC/USC Med Ctr | Los Angeles | California | 90033 | — |
| Kaiser Med Ctr | San Francisco | California | 94110 | — |
| Wilmington Hosp / Med Ctr of Delaware | Wilmington | Delaware | 19899 | — |
| Georgetown Univ Med Ctr | Washington D.C. | District of Columbia | 20007 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | — |
| Cook County Hosp | Chicago | Illinois | 60612 | — |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | — |
| Washington Univ | St Louis | Missouri | 63108 | — |
| Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit | Stony Brook | New York | 117948153 | — |
| Allegheny Univ Hosp | Philadelphia | Pennsylvania | 19129 | — |
| Pittsburgh Treatment Ctr / Univ of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | — |
| Brown Univ / Miriam Hosp | Providence | Rhode Island | 02906 | — |
| Vanderbilt Univ Med Ctr | Nashville | Tennessee | 372321302 | — |
| Univ of Washington / AIDS Clinical Trial Unit | Seattle | Washington | 98104 | — |
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 NCT00002208, 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 Jun 23, 2005 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00002208 live on ClinicalTrials.gov.