A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002340
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997
  Purpose

To assess whether high dose or low dose atovaquone suspension is more effective than aerosolized pentamidine as prophylaxis against Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients. To compare the safety of chronic administration of the three regimens in patients with advanced HIV disease. To determine the relationship between steady state atovaquone plasma concentrations and prophylactic efficacy against PCP.


Condition Intervention Phase
Pneumonia, Pneumocystis Carinii
HIV Infections
Drug: Atovaquone
Drug: Pentamidine isethionate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 615
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002340

Locations
United States, Florida
Goodgame Med Group
Maitland, Florida, United States, 32751
Bay Area AIDS Consortium
Tampa, Florida, United States, 33609
United States, New York
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
United States, Ohio
Holmes Hosp
Cincinnati, Ohio, United States, 452670405
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Sponsors and Collaborators
Glaxo Wellcome
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002340     History of Changes
Other Study ID Numbers: 227B, 230
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Pneumonia, Pneumocystis carinii
Pentamidine
Antifungal Agents
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
atovaquone

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Pneumonia
Pneumonia, Pneumocystis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Pentamidine
Atovaquone
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Trypanocidal Agents
Antimalarials
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014