Completed

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

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What is being tested

Pentamidine isethionate

+ Sulfamethoxazole-Trimethoprim
+ Dapsone
Drug
Who is being recruted

Pneumonia, Pneumocystis Carinii

+ HIV Infections
Over 13 Years
How is the trial designed

Treatment Study

Phase 3
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleA Randomized Trial of Three Anti-Pneumocystis Agents Plus Zidovudine for the Primary Prevention of Serious Infections in Patients With Advanced HIV Infection 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
600 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pneumonia, Pneumocystis Carinii
HIV Infections
Criteria

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 016 and 019). Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: * History of documented or presumed pneumocystosis (PCP) or toxoplasmosis. * Active bacterial or mycobacterial infection. * History of type I hypersensitivity, exfoliative rash, or rash with mucosal involvement, severe bronchospasm, or other life-threatening reaction to any of the study drugs or to other sulfas, sulfones, or pentamidine. * History of intolerance causing dose interruption while receiving zidovudine at equal to or less than 600 mg/day or causing dose reduction to less than 500 mg/day within 4 weeks prior to entry. * Advanced Kaposi's sarcoma or other malignancy not specifically allowed that has been rapidly progressive during the month prior to enrollment or which may be expected to require chemotherapy within 90 days of study entry. Concurrent Medication: Excluded: * Active primary treatment for an infection or malignancy. * Other form of antifolate medication not specifically allowed. * Other antiretroviral or biologic response modifier. * Ganciclovir, if it causes intolerance to AZT equal to or more than 500 mg/day. * Foscarnet. Patients with the following are excluded: * Symptoms and conditions defined in Exclusion Coexisting Conditions. * Glucose 6-phosphate dehydrogenase deficiency (GPD). * History of pneumocystosis (PCP) or toxoplasmosis. * History of type I hypersensitivity, exfoliative rash, or rash with mucosal involvement, severe bronchospasm, or other life-threatening reaction to any of the study drugs or to other sulfas, sulfones, or pentamidine. * History of intolerance causing dose interruption while receiving zidovudine at equal to or less than 500 mg/day with 4 weeks pior to study entry. Prior Medication: Excluded within 4 weeks of study entry: * Any other form of pneumocystosis (PCP) chemoprophylaxis. * Active substance abuse, including alcohol.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 21 locations
Suspended
USC CRSLos Angeles, United StatesSee the location
Suspended
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.Oakland, United States
Suspended
Ucsd, Avrc CrsSan Diego, United States
Suspended
Univ. of Miami AIDS CRSMiami, United States

Completed21 Study Centers