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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000717
First received: November 2, 1999
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Pneumonia, Pneumocystis Carinii
HIV Infections
Drug: Primaquine
Drug: Clindamycin

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 50
Study Completion Date: November 1991
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000717

Locations
United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
United States, Ohio
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Sponsors and Collaborators
Investigators
Study Chair: Black JR
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000717     History of Changes
Other Study ID Numbers: ACTG 044, 11019
Study First Received: November 2, 1999
Last Updated: October 18, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Primaquine
Infusions, Intravenous
Drug Evaluation
Drug Therapy, Combination
Administration, Oral
Acquired Immunodeficiency Syndrome
Clindamycin

Additional relevant MeSH terms:
Infection
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
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Primaquine
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014