The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS

October 18, 2012 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

To determine the safety and effectiveness of clindamycin and primaquine in the treatment of mild Pneumocystis carinii pneumonia (PCP) in AIDS patients.

As many as 80 percent of AIDS patients experience at least one episode of PCP and about one-third of these patients have a recurrence of the disease. Drugs currently used for treatment of acute PCP are toxic to the majority of AIDS patients. The combination of clindamycin and primaquine reduces the numbers of PCP organisms in laboratory tests and in animal studies. Both drugs can be given orally, concentrate in lung tissue, and have been used safely in humans for treatment of other diseases. It is possible that the combination may prove to be as good or better than standard therapy for PCP and side effects may be less.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As many as 80 percent of AIDS patients experience at least one episode of PCP and about one-third of these patients have a recurrence of the disease. Drugs currently used for treatment of acute PCP are toxic to the majority of AIDS patients. The combination of clindamycin and primaquine reduces the numbers of PCP organisms in laboratory tests and in animal studies. Both drugs can be given orally, concentrate in lung tissue, and have been used safely in humans for treatment of other diseases. It is possible that the combination may prove to be as good or better than standard therapy for PCP and side effects may be less.

The proposal for the first 20 patients enrolled in ACTG 044 initially called for an open-labelled, pilot study of intravenous (IV) clindamycin and primaquine therapy in patients with mild to moderate PCP. Preliminary results of the first 22 patients entered into ACTG 044 indicate that the response rate to therapy was over 90 percent. The rate of discontinuation secondary to toxic side effects was only 20 percent. Additional uncontrolled studies have shown an excellent clinical response and safety profile in another 60 patients. The protocol has been amended to provide an all oral dosing regimen. An additional 20 patients with mild PCP will be enrolled and tested with oral clindamycin and primaquine on an outpatient basis. All patients will receive clindamycin and primaquine. Total duration of therapy will be 21 days. Patients may be hospitalized at any time during the study as clinically indicated. Treatment with zidovudine may be started or resumed after completion of clindamycin / primaquine therapy.

AMENDED: An additional 30 patients instead of 20 patients with mild PCP will be enrolled.

Study Type

Interventional

Enrollment

50

Phase

  • Not Applicable

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

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • San Francisco, California, United States, 941102859
        • San Francisco AIDS Clinic / San Francisco Gen Hosp
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Indiana
      • Indianapolis, Indiana, United States, 462025250
        • Indiana Univ Hosp
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Univ Hosp of Cleveland / Case Western Reserve Univ
      • Columbus, Ohio, United States, 432101228
        • Ohio State Univ Hosp Clinic

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

Concurrent Medication:

Allowed:

  • Oral antiemetics.

Patients must have the following for inclusion:

  • HIV positive by ELISA, p24 antigen or culture.
  • Pneumocystis carinii pneumonia (PCP).
  • Patients must have an (A-a) DO2 < 40 mmHg on room air.
  • Willingness to sign an informed consent.

Prior Medication:

Allowed:

- Prophylaxis for Pneumocystis carinii pneumonia (PCP) with agents other than clindamycin and primaquine.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Hematotoxic therapy, including zidovudine (AZT) or ganciclovir.

Patients with the following are excluded:

  • History of allergy to clindamycin, lincomycin, or related drugs; or to primaquine or related drugs.
  • Positive screen for G6PD deficiency, known NAD methemoglobin reductase deficiency, and/or known hemoglobin M abnormality.
  • Concomitant conditions defined in Patient Exclusion Co-Existing Conditions.
  • Any medical or social situation which, in the opinion of the investigator, would adversely affect participation in the study.
  • Note:

Patients may be enrolled while G6PD screen is pending, but must be withdrawn if results are not known within 5 days after entry.

Prior Medication:

Excluded within 14 days of study entry:

  • Systemic steroids at doses exceeding physiologic replacement or other investigational agents.
  • Excluded within 6 weeks of study entry:
  • Prior institution of any antiprotozoal therapy for the current episode of Pneumocystis carinii pneumonia or prophylaxis.

Patients must not have any of the following symptoms or diseases:

  • History of allergy to clindamycin, lincomycin, or related drugs; or to primaquine or related drugs.
  • Positive screen for G6PD deficiency, known NAD methemoglobin reductase deficiency, and/or known hemoglobin M abnormality.
  • Diarrhea, defined as = or > 3 watery stools per day.
  • Severe nausea and vomiting or other medical condition, such as ileus, that precludes oral therapy.
  • Ventilator dependence or (A-a) DO2 = > 30 mm Hg.
  • Any medical or social situation which, in the opinion of the investigator, would adversely affect participation in the study.
  • Note:

Patients may be enrolled while G6PD screen is pending, but must be withdrawn if results are not known within 5 days after entry.

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
  • Masking: None (Open Label)

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)

Investigators

  • Study Chair: Black JR

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

Study Completion (Actual)

November 1, 1991

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)

October 19, 2012

Last Update Submitted That Met QC Criteria

October 18, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 044
  • 11019 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

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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