A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients

February 25, 2011 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Randomized, Double-Blind Study of 566C80 Versus Septra (Trimethoprim/Sulfamethoxazole) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients

To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP.

Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.

Patients are randomized into one of two treatment groups to receive either (1) 566C80 for 21 days, or (2) SMX/TMP for 21 days. Patients will be stratified according to severity of PCP. Group A will be those with an arterial-alveolar (A-a) DO2 < 35 mm Hg. Group B will have an A-a DO2 of 35-45 mm Hg., and will also be required to receive therapy with Corticosteroids. All doses are taken with food. During the 21 days of treatment, patients are examined clinically for adverse effects and have hematology (blood-related) and clinical chemistry studies conducted a minimum of 2 times weekly. More frequent monitoring may be required at the discretion of the investigator. To evaluate the effectiveness of study medication, the clinical status of each patient is evaluated 2 to 3 times per week (e.g., dyspnea score, cough score, chest tightness/pain score, vital signs). Also, on days 7 and 21 of treatment, an arterial blood gas measurement and chest X-ray are performed. Patients who experience severe toxicities will be discontinued from the study and placed on alternative therapy. Patients will also be removed from study if they show significant clinical deterioration within the first 7 days of therapy or if there is no improvement after 10 days of therapy. This study involves a double placebo with one group randomized to receive oral 566C80 and placebo tablets which look like SMX/TMP while the other group will receive SMX/TMP and placebo tablets looking like 566C80.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • CHU Saint Pierre
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Dr Julio S G Montaner
    • Ontario
      • Toronto, Ontario, Canada
        • Wellesley Hosp
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Gen Hosp
  • France
      • Paris, France
        • Hôpital Bichat - Claude Bernard
  • Germany
      • Berlin 41, Germany
        • August-Viktoria-Krankenhaus Chefarst derII Inneren Abteilung
      • Munich 2, Germany
        • Universitat Munchen / Medizinische Poliklinik
  • Netherlands
      • Amsterdam, Netherlands
        • Natac Med Centre
  • Puerto Rico
      • San Juan, Puerto Rico, 009275800
        • San Juan Veterans Administration Med Ctr
  • United Kingdom
      • London, United Kingdom
        • Kobler Centre / Saint Stephen's Hosp
      • London, United Kingdom
        • Saint Mary's Hosp
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham
    • California
      • Harbor City, California, United States, 90710
        • Kaiser Foundation Hosp
      • Los Angeles, California, United States, 90095
        • UCLA CARE Ctr
      • Los Angeles, California, United States, 90033
        • USC
      • Los Angeles, California, United States, 90048
        • Dr Richard Meyer
      • Oakland, California, United States, 94609
        • Infectious Disease Med Group
      • San Diego, California, United States, 921036325
        • Univ of California / San Diego Treatment Ctr
      • San Francisco, California, United States, 94115
        • Dr Marcus Conant
      • San Francisco, California, United States, 941102859
        • San Francisco Gen Hosp
      • San Francisco, California, United States, 94110
        • UCSF - San Francisco Gen Hosp
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
      • Washington, District of Columbia, United States, 20422
        • Veterans Administration Med Ctr
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Dr Winkler Weinberg
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Univ School of Medicine
      • Bethesda, Maryland, United States, 20892
        • Natl Inst of Allergy & Infect Dis / Cln Ctr
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Washington Univ School of Medicine
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr / Peter Krueger Clinic
      • New York, New York, United States, 10037
        • Harlem AIDS Treatment Group / Harlem Hosp Ctr
      • New York, New York, United States, 10011
        • Saint Vincent's Hosp and Med Ctr
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Univ of Cincinnati
    • Oregon
      • Portland, Oregon, United States, 972103079
        • Good Samaritan Hosp
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Buckley Braffman Stern Med Associates
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Regional Med Ctr at Memphis
      • Memphis, Tennessee, United States, 38105
        • The Regional Medical Ctr, Memphis
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77004
        • Plaza Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patient must have the following:

  • Presumptive diagnosis of AIDS as defined by the CDC.
  • Untreated Pneumocystis carinii pneumonia (PCP).
  • Willingness and ability to give informed consent.

Prior Medication:

Allowed:

  • Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) including aerosolized pentamidine or sulfamethoxazole/trimethoprim (SMX/TMP) (at a dose no greater than two DS tablets twice daily).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Judged by the investigator to be in impending respiratory failure.
  • Malabsorption or vomiting that would, in the judgment of investigator, potentially limit the retention and absorption of an oral therapy.
  • Concurrent bacterial, fungal, or viral pneumonitis, pulmonary Kaposi's sarcoma or other concurrent illness, or chronic pulmonary disease that, in the investigator's opinion, would make interpretation of drug efficacy difficult.

Concurrent Medication:

Excluded:

  • Corticosteroid treatment (except replacement therapy or patients in Group B).
  • Ganciclovir.
  • Zidovudine (AZT).
  • Investigational agents including antiretroviral agents (didanosine (ddI), dideoxycytidine (ddC), etc.).

Drugs likely to have anti-pneumocystis effect such as:

  • Sulfonamides.
  • Pentamidine.
  • Dapsone.
  • Trimethoprim.
  • Other DHFR inhibitors.
  • Primaquine.
  • Clindamycin.
  • Sulfonylureas.

Patients with the following are excluded:

  • Judged by the investigator to be in impending respiratory failure.
  • Prior therapy for this episode of PCP or treatment within 4 weeks of entry for a prior episode of PCP.
  • Unable to or refuse to discontinue zidovudine, ganciclovir, or other antiretroviral agents during the 21 day treatment period.
  • Unable to take medication orally or unwilling or unable to take study medication with food.
  • Significant psychosis or emotional disorder such that, in the investigator's opinion, the patient would not be compliant with the study protocol.
  • Prior documented glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Prior history of life-threatening toxicity to SMX/TMP such as severe rash or Stevens-Johnson syndrome.

Prior Medication:

Excluded:

  • Prior therapy for this episode of Pneumocystis carinii pneumonia (PCP) or treatment within 4 weeks for a prior episode of PCP.
  • Blood transfusions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Glaxo Wellcome

Investigators

  • Study Chair: Hughes WT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

January 1, 1992

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

March 1, 2011

Last Update Submitted That Met QC Criteria

February 25, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 167
  • NIAID 90-CC-185
  • Protocol #03
  • FDA 53A
  • Project P71

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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