Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00001011 · ClinicalTrials.gov registry record · Phase 3
The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 538
- Enrollment target
NCT00001011: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001011 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 538 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001011, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 538 participants
- Enrollment target
Study Summary
To determine the safety and usefulness of zidovudine (AZT) for the treatment of patients with early symptomatic HIV infection or early AIDS related complex (ARC). The ability of AZT to suppress HIV, to improve body defenses, and to prevent the occurrence or development of AIDS or advanced ARC is being evaluated. In one human study, patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections, improved in weight and performance, and lived longer than patients who received a placebo (inactive medication). Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown. It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL.
Interventions
- DRUG Zidovudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 538 participants |
| Est. Completion | 1995-02 |
| Phase | Phase 3 |
What the finished NCT00001011 record still lists
NCT00001011 is an interventional study that assigns participants to a tested intervention. The registered 538 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 (30% lower).
The record links to 0 conditions, and to 1 intervention - of which Zidovudine is the first listed.
NCT00001011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001011 about?
NCT00001011 is a clinical study titled "The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex". To determine the safety and usefulness of zidovudine (AZT) for the treatment of patients with early symptomatic HIV infection or early AIDS related complex (ARC). The ability of AZT to suppress HIV, to improve body defenses, and to prevent the occurrence or development of AIDS or advanced ARC is bei...
What is the current status of trial NCT00001011?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 538 participants. Estimated completion is 1995-02.
What interventions are being tested in trial NCT00001011?
The interventions under investigation include: Zidovudine (DRUG).
Who is sponsoring clinical trial NCT00001011?
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 NCT00001011's enrollment target sits among peer trials
538 700th of 2000 higher than 1,300 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
- NCT03772028 · 538 participants · Phase 3
Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
- NCT06538038 · 538 participants
Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
- NCT05880004 · 537 participants · NA
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
- NCT04557462 · 540 participants · Phase 3
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy