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NCT00001095 · ClinicalTrials.gov registry record · Phase 2
A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
NCT00001095 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 94 participants.
The verdict
NCT00001095, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Lamivudine
- DRUG Indinavir sulfate
- DRUG Stavudine
- DRUG Nevirapine
- DRUG Amprenavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Est. Completion | 1999-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001095
The ClinicalTrials.gov registry entry for NCT00001095 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Lamivudine is the first listed.
NCT00001095 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001095 about?
NCT00001095 is a clinical study titled "A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir". 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, ...
What is the current status of trial NCT00001095?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. Estimated completion is 1999-10.
What interventions are being tested in trial NCT00001095?
The interventions under investigation include: Lamivudine (DRUG), Indinavir sulfate (DRUG), Stavudine (DRUG), Nevirapine (DRUG), Amprenavir (DRUG).
Who is sponsoring clinical trial NCT00001095?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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