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NCT00000903 · ClinicalTrials.gov registry record · Phase 3
Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 444
- Enrollment target
NCT00000903 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 444 participants.
The verdict
NCT00000903, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 444 participants
- Enrollment target
Study Summary
To compare time to a virologic failure (first of 2 consecutive plasma HIV RNA levels greater than or equal to 200 copies/ml at or after Week 24) of each 4-drug regimen vs the 3-drug regimen. To determine the safety, tolerance, and virologic benefits of either nelfinavir (NFV) or efavirenz (EFV) with indinavir/lamivudine/zidovudine (IDV/3TC/ZDV) vs IDV/3TC/ZDV alone, in the treatment of patients with advanced HIV disease who have received limited or no prior antiretroviral therapy. Prior ACTG studies have shown that the 3-drug combination regimen (IDV/ZDV/3TC) resulted in improved clinical outcomes and therefore may prolong the effects of therapy. The enhanced effects seen with combination therapies are likely related to a greater suppression of RNA replication and alterations in resistance patterns. Due to the progressive success of combination regimens, it is possible that more potent regimens will further enhance viral suppression and provide more durable treatment responses. In light of the additive suppression of HIV replication determined by pharmacological, immunological, and virological results, nelfinavir (NFV) as an addition to IDV/ZDV/3TC will be evaluated. Based on the potency of nonnucleoside reverse transcriptase inhibitors (NNRTIs) to suppress viral replication and the effectiveness of 3-drug regimens containing NNRTIs, efavirenz (EFV) will also be evaluated as an addition to IDV/ZDV/3TC.
Interventions
- DRUG Efavirenz
- DRUG Indinavir sulfate
- DRUG Nelfinavir mesylate
- DRUG Lamivudine/Zidovudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Est. Completion | 2001-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000903
The ClinicalTrials.gov registry entry for NCT00000903 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 444 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 4 interventions - of which Efavirenz is the first listed.
NCT00000903 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000903 about?
NCT00000903 is a clinical study titled "Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen". To compare time to a virologic failure (first of 2 consecutive plasma HIV RNA levels greater than or equal to 200 copies/ml at or after Week 24) of each 4-drug regimen vs the 3-drug regimen. To determine the safety, tolerance, and virologic benefits of either nelfinavir (NFV) or efavirenz (EFV) with...
What is the current status of trial NCT00000903?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 444 participants. Estimated completion is 2001-07.
What interventions are being tested in trial NCT00000903?
The interventions under investigation include: Efavirenz (DRUG), Indinavir sulfate (DRUG), Nelfinavir mesylate (DRUG), Lamivudine/Zidovudine (DRUG).
Who is sponsoring clinical trial NCT00000903?
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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