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The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS Clinical research trials and The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS. The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS clinical trial. Participants typically obtain the most effective healthcare available for their The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS  The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS
The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
BlackJR, Study Chair,
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Additional Information:
Study ID Numbers: ACTG 044;
Study Start Date:
Record last reviewed: February 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000717
Other Pneumonia, Pneumocystis Carinii Studies:
1. A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
2. A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis carinii Pneumonia in Patients With AIDS Post First Episode PCP
3. A Study of Trimetrexate in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Not Previously Treated for PCP
4. Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis carinii Pneumonia
5. A Treatment IND for 566C80 Therapy of Pneumocystis carinii Pneumonia
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The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS
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