A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients
- Conditions
- HIV InfectionsPneumonia, Pneumocystis Carinii
- Registration Number
- NCT00000991
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Case CRS
🇺🇸Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States
Pitt CRS
🇺🇸Pittsburgh, Pennsylvania, United States
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
🇹🇿Mbeya, Tanzania
USC CRS
🇺🇸Los Angeles, California, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
🇺🇸Oakland, California, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
🇺🇸Boston, Massachusetts, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Duke Univ. Med. Ctr. Adult CRS
🇺🇸Durham, North Carolina, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States