CompletedPhase 3

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

United States600 participants

Plain-language 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.

Who can participate

Age range13 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Concurrent Medication: Allowed: * Antifolate medication required to treat an intercurrent infection. * Treatment of intercurrent infections or malignancies. * Fluconazole. * Itraconazole. * Standard or investigational therapy for pneumocystosis (PCP) or toxoplasmosis. * Only the forms of primary prophylaxis for PCP or toxoplasmosis assigned to the participant under the protocol. Patients who develop intolerance to all forms of prophylaxis assigned in this protocol or who develop PCP or toxoplasmosis may receive alternate or investigation forms of prophylaxis with or without zidovudine but must continue to be followed under this protocol. * Discouraged but allowed: AL-721. * Chronic acyclovir. * Ketoconazole. * Amphotericin B. * Corticosteroids at greater than physiologic replacement doses are strongly discouraged. * They should be used as briefly as possible and only for definite specific indications. Patient must conform to the following: * Receiving or candidates for zidovudine therapy at least 500 mg/day under current labeled indications with no history of pneumocystosis (PCP) or toxoplasmosis. * Evidence of HIV infection documented by HIV antibody tests. * T4 cell count less than 200 cells/mm3 at any time prior to study entry. * Willing to sign informed consent. * Willing to be followed by a participating ACTG center for duration of the study. * Allowed: Concurrent enrollment in long-term follow-up studies in previously blinded trials of AZT (ACTG …

Trial details

NCT IDNCT00000991

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL