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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002340
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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 or disease Intervention/treatment Phase
Pneumonia, Pneumocystis Carinii HIV Infections Drug: Atovaquone Drug: Pentamidine isethionate Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 615 participants
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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Pneumonia

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • Antimicrobial agents not specifically prohibited.

Concurrent Treatment:


  • 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.


  • 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:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002340

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

Publications: Identifier: NCT00002340     History of Changes
Other Study ID Numbers: 227B
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 1997

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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
Pneumocystis Infections
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Trypanocidal Agents