A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir
Public ClinicalTrials.gov record NCT00001095. 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
A Phase II Study of 1) Amprenavir (141W94/VX478) Plus 3TC Plus ZDV (or d4T) or 2) IDV Plus NVP Plus 3TC Plus d4T in Subjects Previously Treated With Amprenavir and 3) Other Treatment Regimens (Observational ARM) in Subjects Previously Treated With Amprenavir
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To determine the proportion of patients treated with amprenavir, zidovudine (ZDV), stavudine (D4T) and lamivudine (3TC) whose HIV-1 RNA level remains below the level of detection during 96 weeks of therapy. To determine the proportion of patients treated with indinavir (IDV), nevirapine (NVP), 3TC, and d4T whose HIV-1 RNA level decreases and then remains below the level of detection, during the 96-week therapy period. To determine the viral effects, safety, tolerability, and pharmacokinetics of amprenavir in combination with zidovudine, stavudine, and lamivudine. \[AS PER AMENDMENT 2/27/98: To determine the proportion of patients with undetectable plasma HIV RNA, by treatment and baseline RNA cohort (either detectable or undetectable). To determine the durability of these regimens by estimating the distribution of time to loss of virologic suppression (or equivalently, time to virologic failure), by treatment and baseline RNA cohort.\] This study allows patients who have successfully participated in ACTG 347 or other trials involving amprenavir to continue treatment with amprenavir, ZDV, d4T, and 3TC. Additionally, this study provides patients whose HIV-1 RNA was not reduced to undetectable levels or who had a significant increase in plasma levels ("treatment failures") the opportunity to change to a potentially more active regimen that includes indinavir, nevirapine, lamivudine, and stavudine.
Study identification
- NCT ID
- NCT00001095
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 94 participants
Conditions and interventions
Conditions
Interventions
- Indinavir sulfate Drug
- Amprenavir Drug
- Nevirapine Drug
- Lamivudine Drug
- Stavudine Drug
- Zidovudine Drug
Drug
Eligibility (public fields only)
- Age range
- 13 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
- Sep 30, 1999
- Last update posted
- Nov 3, 2021
Ends 1999
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Southern California / LA County USC Med Ctr | Los Angeles | California | 900331079 | — |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | — |
| Univ of Miami School of Medicine | Miami | Florida | 331361013 | — |
| Emory Univ | Atlanta | Georgia | 30308 | — |
| Cook County Hosp | Chicago | Illinois | 60612 | — |
| Boston Med Ctr | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess - West Campus | Boston | Massachusetts | 02215 | — |
| St Louis Regional Hosp / St Louis Regional Med Ctr | St Louis | Missouri | 63112 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Univ of North Carolina | Chapel Hill | North Carolina | 275997215 | — |
| Univ of Pennsylvania at Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Julio Arroyo | West Columbia | South Carolina | 29169 | — |
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 NCT00001095, 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 3, 2021 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00001095 live on ClinicalTrials.gov.