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Completed Phase 3 Interventional

A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients

ClinicalTrials.gov ID: NCT00000991

Public ClinicalTrials.gov record NCT00000991. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 5:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Trial of Three Anti-Pneumocystis Agents Plus Zidovudine for the Primary Prevention of Serious Infections in Patients With Advanced HIV Infection

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00000991
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
600 participants

Conditions and interventions

Eligibility (public fields only)

Age range
13 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Mar 31, 1994
Last update posted
Nov 3, 2021

Ends 1994

United States locations

U.S. sites
20
U.S. states
13
U.S. cities
18
Facility City State ZIP Site status
USC CRS Los Angeles California 90033
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. Oakland California 94609
Ucsd, Avrc Crs San Diego California 92103
Univ. of Miami AIDS CRS Miami Florida 33136
Chicago Children's CRS Chicago Illinois 60614
Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana 46202
Johns Hopkins Adult AIDS CRS Baltimore Maryland 21287
Massachusetts General Hospital ACTG CRS Boston Massachusetts 02114
Beth Israel Deaconess - East Campus A0102 CRS Boston Massachusetts 02215
Beth Israel Deaconess Med. Ctr., ACTG CRS Boston Massachusetts 02215
University of Minnesota, ACTU Minneapolis Minnesota 55455
Washington U CRS St Louis Missouri
SUNY - Buffalo, Erie County Medical Ctr. Buffalo New York 14215
Univ. of Rochester ACTG CRS Rochester New York
Unc Aids Crs Chapel Hill North Carolina
Duke Univ. Med. Ctr. Adult CRS Durham North Carolina
Case CRS Cleveland Ohio 44106
The Ohio State Univ. AIDS CRS Columbus Ohio 43210
Pitt CRS Pittsburgh Pennsylvania
University of Washington AIDS CRS Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00000991, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 3, 2021 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00000991 live on ClinicalTrials.gov.

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