A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients
A Randomized Trial of Three Anti-Pneumocystis Agents Plus Zidovudine for the Primary Prevention of Serious Infections in Patients With Advanced HIV Infection
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
A PHASE3 clinical study on HIV Infections and Pneumonia, Pneumocystis Carinii, this trial is completed. The trial is conducted by National Institute of Allergy and Infectious Diseases (NIAID) and has accumulated 7 data snapshots since 2026. Infectious disease trials contribute critical data for public health response and treatment development.
Study Description(click to expand)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.
All patients receive AZT. In addition, they are placed in one of three groups to receive either SMX/TMP, dapsone, or PEN. Stratification criteria are:
Received first AZT equal to or less than 6 weeks prior to study entry. Received first AZT more than 6 weeks prior to study entry. Potential to participate in ACTG 981. ACTG center in which the patient is enrolled.
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.
All patients receive AZT. In addition, they are placed in one of three groups to receive either SMX/TMP, dapsone, or PEN. Stratification criteria are:
Received first AZT equal to or less than 6 weeks prior to study entry. Received first AZT more than 6 weeks prior to study entry. Potential to participate in ACTG 981. ACTG center in which the patient is enrolled.
Status Flow
Change History
7 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Dec 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Dec 2021 [monthly]
Completed PHASE3
▶ Show 2 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
-
Jan 2017 — Jun 2018 [monthly]
Completed PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- National Institute of Allergy and Infectious Diseases (NIAID)
For direct contact, visit the study record on ClinicalTrials.gov .