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NCT00001086 · ClinicalTrials.gov registry record · Phase 2
A Study of Abacavir Plus Indinavir Sulfate Plus Efavirenz in HIV-Infected Patients
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
NCT00001086 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 300 participants.
The verdict
NCT00001086, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
Study Summary
To compare the virologic response between abacavir (ABC, 1592U89) regimens (drug vs. placebo) and between the 2 dosing regimens (BID vs. TID) with respect to the proportion of patients with plasma HIV RNA levels below the limit of detection \[AS PER AMENDMENT 8/27/97: \< 500 copies/ml at week 16\]. To evaluate the safety and tolerance of the study arms. \[AS PER AMENDMENT 3/10/99: During the extension period, compare the time to detectable viremia (2 consecutive plasma HIV RNA levels greater than or equal to 500 copies/ml) between ABC and placebo.\] Therapeutically, there is a need to explore potent alternative therapy for patients who have received, or are currently receiving, a double nucleoside analog combination including lamivudine (3TC), a regimen that was proven to be clinically inferior to indinavir (IDV) when combined with zidovudine/3TC in study ACTG 320. In order to produce and maintain a maximal antiviral response, all patients in this study will receive 2 or 3 potent, new agents; ABC, a nucleoside analog, EFV, a non-nucleoside reverse transcriptase inhibitor (NNRTI), and IDV, a protease inhibitor. Virologically, the major question this protocol seeks to answer is how prior 3TC exposure in a dual nucleoside regimen influences the response to subsequent treatment. It is unclear whether it is best to add a protease inhibitor either 1) an NNRTI at 1 of 2 doses, or 2) an NNRTI at 1 of 2 doses plus a new nucleoside analog to achieve plasma HIV RNA levels that are below the limits of detection.
Interventions
- DRUG Efavirenz
- DRUG Indinavir sulfate
- DRUG Abacavir sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Est. Completion | 1999-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001086
The ClinicalTrials.gov registry entry for NCT00001086 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 300 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 3 interventions - of which Efavirenz is the first listed.
NCT00001086 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001086 about?
NCT00001086 is a clinical study titled "A Study of Abacavir Plus Indinavir Sulfate Plus Efavirenz in HIV-Infected Patients". To compare the virologic response between abacavir (ABC, 1592U89) regimens (drug vs. placebo) and between the 2 dosing regimens (BID vs. TID) with respect to the proportion of patients with plasma HIV RNA levels below the limit of detection \[AS PER AMENDMENT 8/27/97: \< 500 copies/ml at week 16\]. ...
What is the current status of trial NCT00001086?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. Estimated completion is 1999-09.
What interventions are being tested in trial NCT00001086?
The interventions under investigation include: Efavirenz (DRUG), Indinavir sulfate (DRUG), Abacavir sulfate (DRUG).
Who is sponsoring clinical trial NCT00001086?
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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