The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS
Pneumonia, Pneumocystis Carinii, HIV Infections
About this trial
This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Primaquine, Infusions, Intravenous, Drug Evaluation, Drug Therapy, Combination, Administration, Oral, Acquired Immunodeficiency Syndrome, Clindamycin
Eligibility 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 Note: Patients may be enrolled while G6PD screen is pending, but must be withdrawn if results are not known within 5 days after entry.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.
Sites / Locations
- Los Angeles County - USC Med Ctr
- San Francisco AIDS Clinic / San Francisco Gen Hosp
- Northwestern Univ Med School
- Rush Presbyterian - Saint Luke's Med Ctr
- Indiana Univ Hosp
- Univ Hosp of Cleveland / Case Western Reserve Univ
- Ohio State Univ Hosp Clinic