A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients
Status:
Completed
Trial end date:
1994-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Dapsone Pentamidine Sulfamethoxazole Trimethoprim Trimethoprim, Sulfamethoxazole Drug Combination Zidovudine