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

Primary Purpose

Pneumonia, Pneumocystis Carinii, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Atovaquone
Pentamidine isethionate
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Pneumonia, Pneumocystis carinii, Pentamidine, Antifungal Agents, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, atovaquone

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Goodgame Med Group
  • Bay Area AIDS Consortium
  • Saint Vincent's Hosp and Med Ctr
  • Holmes Hosp
  • Hampton Roads Med Specialists

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002340
Brief Title
A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis Carinii, HIV Infections
Keywords
Pneumonia, Pneumocystis carinii, Pentamidine, Antifungal Agents, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, atovaquone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
615 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atovaquone
Intervention Type
Drug
Intervention Name(s)
Pentamidine isethionate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Goodgame Med Group
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Bay Area AIDS Consortium
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Saint Vincent's Hosp and Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Holmes Hosp
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10395851
Citation
Chan C, Montaner J, Lefebvre EA, Morey G, Dohn M, McIvor RA, Scott J, Marina R, Caldwell P. Atovaquone suspension compared with aerosolized pentamidine for prevention of Pneumocystis carinii pneumonia in human immunodeficiency virus-infected subjects intolerant of trimethoprim or sulfonamides. J Infect Dis. 1999 Aug;180(2):369-76. doi: 10.1086/314893.
Results Reference
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A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX

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