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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000991
The ClinicalTrials.gov registry entry for NCT00000991 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 600 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 Zidovudine is the first listed.
NCT00000991 reports 0 study locations.
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.
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