Completed

A Randomized, Open-Label Trial of High Dose Atovaquone Versus Low Dose Atovaquone Versus Aerosolized Pentamidine for Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With HIV Infection Who Are Intolerant of TMP/SMX

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Atovaquone

+ Pentamidine isethionate

Drug
Who is being recruted

Blood-Borne Infections+23

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Patients are randomized to receive oral atovaquone at 1 of 2 doses once daily or aerosolized pentamidine once every 4 weeks. Treatment continues until 18 months after the last patient is enrolled. Patients are stratified into primary or secondary prophylaxis strata based on prior occurrence of a PCP episode.

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
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

615 patients to be enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLung DiseasesLung Diseases, FungalMycosesPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsPneumocystis InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexPneumonia, PneumocystisHIV Infections

Criteria

Inclusion Criteria Concurrent Medication: Allowed: Antimicrobial agents not specifically prohibited. Concurrent Treatment: Allowed: Transfusion. Patients must have: HIV positivity. Prior PCP (histologically confirmed) OR documented CD4 count < 200 cells/mm3 OR constitutional symptoms such as thrush or unexplained fever (> 100 F) for 2 or more weeks. No current or suspected active PCP, and no signs of active PCP on chest x-ray. Prior intolerance to TMP/SMX or other trimethoprim or sulfa-containing regimens. Life-expectancy of at least 6 months. NOTE: Pregnant women are eligible at the discretion of the investigator. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Significant psychosis or emotional disorder that would preclude study compliance. Severe chronic diarrhea (e.g., > five stools/day) that may negatively affect absorption of oral medication. Unable to take oral medication or unable or unwilling to take medication with food. Concurrent Medication: Excluded: Rifampin. Other investigational agents except for drugs available through Treatment INDs or expanded access programs. Medications likely to have anti-pneumocystis effect (e.g., dapsone, trimethoprim, pyrimethamine, trimetrexate, other DHFR inhibitors, sulfadiazine, sulfamethoxazole, other sulfonamides, primaquine, clindamycin, and sulfonylureas. Corticosteroids in greater than physiologic replacement doses for more than 21 consecutive days. Systemic therapy for CNS toxoplasmosis, Kaposi's sarcoma, lymphoma, other active malignancies, or other disease that may decrease life expectancy or confound assessment. Patients with the following prior conditions are excluded: History of severe or intractable intolerance to atovaquone or aerosolized pentamidine. Prior hypoglycemia, pancreatitis, arrhythmias, or severe hypotension associated with any form of pentamidine. Prior enrollment in this protocol. Active substance abuse that would preclude study compliance.

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 5 locations

Goodgame Med Group

Maitland, United StatesOpen Goodgame Med Group in Google Maps

Bay Area AIDS Consortium

Tampa, United States

Saint Vincent's Hosp and Med Ctr

New York, United States

Holmes Hosp

Cincinnati, United States
Completed5 Study Centers