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

NCT00000717 | Completed

• 2 other identifiers: ACTG 04411019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Pneumonia, Pneumocystis Carinii; HIV Infections

Keywords

AIDS-Related Opportunistic Infections; Pneumonia, Pneumocystis carinii; Primaquine; Infusions, Intravenous; Drug Evaluation; Drug Therapy, Combination; Administration, Oral; Acquired Immunodeficiency Syndrome; Clindamycin

Interventions

Primaquine DRUG

Clindamycin DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Oral antiemetics.
• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (7)

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Indiana Univ Hosp

Indianapolis, Indiana, 462025250, United States

Location

Univ Hosp of Cleveland / Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Related Publications (2)

• Black JR, Feinberg J, Murphy RL, Fass RJ, Carey J, Sattler FR. Clindamycin and primaquine as primary treatment for mild and moderately severe Pneumocystis carinii pneumonia in patients with AIDS. Eur J Clin Microbiol Infect Dis. 1991 Mar;10(3):204-7. doi: 10.1007/BF01964465.

  PMID: 2060532 BACKGROUND

• Black JR, Feinberg J, Murphy RL, Fass RJ, Finkelstein D, Akil B, Safrin S, Carey JT, Stansell J, Plouffe JF, et al. Clindamycin and primaquine therapy for mild-to-moderate episodes of Pneumocystis carinii pneumonia in patients with AIDS: AIDS Clinical Trials Group 044. Clin Infect Dis. 1994 Jun;18(6):905-13. doi: 10.1093/clinids/18.6.905.

  PMID: 8086551 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Pneumocystis; HIV Infections; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome

Interventions

Primaquine; Clindamycin

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates

Study Officials

• Black JR

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: November 1, 1991
• Last Updated: October 19, 2012

Record last verified: 2012-10

Locations

US (7)