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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000717 |
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 |
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Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Primaquine Drug: Clindamycin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS |
Estimated Enrollment: | 50 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have the following for inclusion:
Prior Medication:
Allowed:
- Prophylaxis for Pneumocystis carinii pneumonia (PCP) with agents other than clindamycin and primaquine.
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients with the following are excluded:
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:
Patients must not have any of the following symptoms or diseases:
Patients may be enrolled while G6PD screen is pending, but must be withdrawn if results are not known within 5 days after entry.
United States, California | |
San Francisco AIDS Clinic / San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
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 | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
Univ Hosp of Cleveland / Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 |
Study Chair: | Black JR |
Study ID Numbers: | ACTG 044 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000717 |
Health Authority: | United States: Federal Government |
AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Primaquine Infusions, Intravenous Drug Evaluation |
Drug Therapy, Combination Administration, Oral Acquired Immunodeficiency Syndrome Clindamycin |
Opportunistic Infections Clindamycin Sexually Transmitted Diseases, Viral Primaquine Clindamycin-2-phosphate Pneumocystosis Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Mycoses Pneumonia, Pneumocystis |
Pneumocystis Infections Respiratory Tract Infections Respiratory Tract Diseases HIV Infections Lung Diseases AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Retroviridae Infections Pneumonia Lung Diseases, Fungal |
Anti-Infective Agents Antiprotozoal Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Pharmacologic Actions Protein Synthesis Inhibitors Anti-Bacterial Agents Antimalarials Antiparasitic Agents Therapeutic Uses Lentivirus Infections |