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NCT00001084 · ClinicalTrials.gov registry record · Phase 2
A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT00001084: Completed Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001084 is a Phase 2 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 500 participants, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001084, a Phase 2 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
To compare the proportion of patients who sustain suppression of plasma HIV RNA to undetectable levels \[AS PER AMENDMENT 09/19/97: below 200 copies/mL by Roche UltraSensitive assay\] among the 3 regimens during the maintenance phase. The objective of antiretroviral therapy is to reduce HIV replication, preserve immunologic function and delay the development of HIV-related complications. In patients administered potent antiretroviral regimens, HIV RNA levels are reduced below 500 copies/ml of plasma and below the level of detection of commercially available assays. This protocol attempts to learn if a less intensive regimen can successfully sustain viral suppression after induction with a triple-drug regimen. The study also addresses whether HIV can be eradicated in patients following prolonged treatment with induction and maintenance regimens.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Lamivudine
- DRUG Indinavir sulfate
- DRUG Stavudine
Study Locations (20)
California
- Univ of Southern California / LA County USC Med Ctr - Los Angeles
- Univ of California / San Diego Treatment Ctr - San Diego
- San Francisco Gen Hosp - San Francisco
- Stanford at Kaiser / Kaiser Permanente Med Ctr - San Francisco
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium - San Jose
- San Mateo AIDS Program / Stanford Univ - Stanford
- Stanford Univ Med Ctr - Stanford
- Harbor UCLA Med Ctr - Torrance
Hawaii
- Queens Med Ctr - Honolulu
- Univ of Hawaii - Honolulu
Illinois
- Northwestern Univ Med School - Chicago
- Cook County Hosp - Chicago
Indiana
- Indiana Univ Hosp - Indianapolis
- Division of Inf Diseases/ Indiana Univ Hosp - Indianapolis
Louisiana
- Tulane Med Ctr Hosp - New Orleans
- Tulane Univ School of Medicine - New Orleans
Colorado
- Univ of Colorado Health Sciences Ctr - Denver
Florida
- Univ of Miami School of Medicine - Miami
Georgia
- Emory Univ - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Est. Completion | 1997-12 |
| Phase | Phase 2 |
What the finished NCT00001084 record still lists
NCT00001084 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (12% higher).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Zidovudine is the first listed.
NCT00001084 names 20 study sites across 9 states, led by California, Hawaii, Illinois.
Frequently Asked Questions
What is clinical trial NCT00001084 about?
NCT00001084 is a clinical study titled "A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients". To compare the proportion of patients who sustain suppression of plasma HIV RNA to undetectable levels \[AS PER AMENDMENT 09/19/97: below 200 copies/mL by Roche UltraSensitive assay\] among the 3 regimens during the maintenance phase. The objective of antiretroviral therapy is to reduce HIV replica...
What is the current status of trial NCT00001084?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 500 participants. Estimated completion is 1997-12.
What conditions does trial NCT00001084 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00001084?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Indinavir sulfate (DRUG), Stavudine (DRUG).
Who is sponsoring clinical trial NCT00001084?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001084 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001084's enrollment target sits among peer trials
500 62nd of 542 higher than 479 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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