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NCT00000991 · ClinicalTrials.gov registry record · Phase 3
A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
NCT00000991: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000991 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 600 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000991, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
Study Summary
To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with HIV infection and T4 cell count less than 200 cells/mm3. All persons completing at least 8 weeks of therapy on 081 will be offered the opportunity to participate in the nested study (ACTG 981) of systemic antifungal therapy (fluconazole) versus local therapy (Clotrimazole) for the prevention of serious fungal disease. Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial pneumonia, and other serious infections. It is therefore important to find drugs that can be given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis.
Interventions
- DRUG Zidovudine
- DRUG Dapsone
- DRUG Pentamidine isethionate
- DRUG Sulfamethoxazole-Trimethoprim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Est. Completion | 1994-04 |
| Phase | Phase 3 |
What the finished NCT00000991 record still lists
NCT00000991 is an interventional study that assigns participants to a tested intervention. The registered 600 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 (22% lower).
The record links to 0 conditions, and to 4 interventions - of which Zidovudine is the first listed.
NCT00000991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000991 about?
NCT00000991 is a clinical study titled "A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients". To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with HIV infection and T4 cell count less than 200 cells/mm3. All persons completing at least 8 weeks of therapy on 081 will be offered the opportunity to participate in the nested study (ACTG 981) of systemic anti...
What is the current status of trial NCT00000991?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 600 participants. Estimated completion is 1994-04.
What interventions are being tested in trial NCT00000991?
The interventions under investigation include: Zidovudine (DRUG), Dapsone (DRUG), Pentamidine isethionate (DRUG), Sulfamethoxazole-Trimethoprim (DRUG).
Who is sponsoring clinical trial NCT00000991?
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 NCT00000991's enrollment target sits among peer trials
600 608th of 2000 higher than 1,363 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
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