Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00000903 record still lists
NCT00000903 is an interventional study that assigns participants to a tested intervention. The registered 444 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 4 interventions - of which Efavirenz is the first listed.
NCT00000903 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000903's enrollment target sits among peer trials
444 864th of 2000 higher than 1,135 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06348394 · 444 participants · NA
Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion
- NCT06700343 · 444 participants · Phase 3
Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)
- NCT01280994 · 445 participants · Phase 2
Hyperpolarized 129Xe MRI for Imaging Pulmonary Function
- NCT03504800 · 445 participants
OCT in Diagnosis of Irregular Corneas