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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000640
Other study ID # ACTG 108
Secondary ID 11083
Status Completed
Phase Phase 3
First received
Last updated
Est. completion date September 1994

Study information

Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.


Description:

The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation. Patients with confirmed PCP are randomized into one of three treatment groups. Group A receives SMX/TMP. Half of group A receives dapsone placebo (placebo is an inactive substance) daily plus trimethoprim placebo; the other half receives clindamycin placebo plus primaquine placebo. Group B is given dapsone plus trimethoprim. Half of group B receives SMX/TMP placebo; the other half receives clindamycin placebo plus primaquine placebo. Group C is given clindamycin plus primaquine. Half of group C receives SMX/TMP placebo, the other half receives dapsone placebo plus trimethoprim placebo. Treatment lasts 21 days; dosages will be adjusted for patients weighing less than 50 kg and more than 80 kg. Patients with a history of intolerance to SMX/TMP for whom rechallenge is considered medically contraindicated may be randomized to one of the non-sulfamethoxazole-containing arms.


Recruitment information / eligibility

Status Completed
Enrollment 290
Est. completion date September 1994
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility Inclusion Criteria Concurrent Medication: Allowed: - Erythropoietin. - Maintenance treatment with investigational triazoles (e.g., itraconazole). - Antiemetics for nausea/vomiting, antihistamines for rash/pruritus, antipyretics for systemic symptoms (fever, headache, etc.) should be used for treatment of symptoms. - Nonsteroidal antiinflammatory agents may be used for control of myalgias, headache, etc. Concurrent Treatment: Allowed: - Blood transfusions. Patients must have the following: - Pneumocystis carinii pneumonia. - HIV infection. - Willing and able to sign informed consent. Patients under 18 years of age may enter with consent of parent or guardian. Prior Medication: Allowed: - Up to 24 hours of treatment with sulfamethoxazole/trimethoprim (SMX/TMP), dapsone / trimethoprim, or clindamycin / primaquine, or one dose of pentamidine for this episode of Pneumocystis carinii pneumonia (PCP). - Prior PCP prophylaxis. Required: - Adjunctive prednisone therapy in patients with (A-a) DO2 of 35 - 45 torr receiving acute anti-PCP treatment. Exclusion Criteria Co-existing Condition: Patients with the following conditions and diseases are excluded: Positive screen for glucose-6-phosphate dehydrogenase deficiency. - Known NAD methemoglobin reductase deficiency and/or known hemoglobin M abnormality. Concurrent Medication: Excluded: - Zidovudine (AZT). - Ganciclovir. - GM-CSF or G-CSF. Rifampin. - Rifabutin. - Corticosteroids (in patients with baseline (A-a) DO2 < 35 torr). Investigational drugs not specifically allowed. - Folinic acid. Patients with the following are excluded: - Previous dose-limiting intolerance to sulfones, trimethoprim, clindamycin, or primaquine. Requirement for other medications potentially effective in the treatment of Pneumocystis carinii pneumonia (PCP) (e.g., pyrimethamine and sulfadiazine). - Prior enrollment in ACTG 108. Presence of other concurrent pulmonary pathology that would make interpretation of response to antipneumocystis therapy difficult. Inability to take oral therapy. Prior Medication: Excluded: - Acute treatment doses of anti-Pneumocystis carinii pneumonia agents within 30 days prior to study entry except as noted above. - Systemic steroids above adrenal replacement doses within 7 days prior to study entry (except for patients with (A-a) DO2 of 35 - 45 torr who receive prednisone in conjunction with acute anti-PCP treatment).

Study Design


Intervention

Drug:
Primaquine

Sulfamethoxazole-Trimethoprim

Dapsone

Clindamycin


Locations

Country Name City State
United States University of Colorado Hospital CRS Aurora Colorado
United States Johns Hopkins Adult AIDS CRS Baltimore Maryland
United States Beth Israel Deaconess - East Campus A0102 CRS Boston Massachusetts
United States Massachusetts General Hospital ACTG CRS Boston Massachusetts
United States SUNY - Buffalo, Erie County Medical Ctr. Buffalo New York
United States Unc Aids Crs Chapel Hill North Carolina
United States Carolinas HealthCare System, Carolinas Med. Ctr. Charlotte North Carolina
United States Northwestern University CRS Chicago Illinois
United States Rush Univ. Med. Ctr. ACTG CRS Chicago Illinois
United States Univ. of Cincinnati CRS Cincinnati Ohio
United States Case CRS Cleveland Ohio
United States The Ohio State Univ. AIDS CRS Columbus Ohio
United States Regional Center for Infectious Disease, Wendover Medical Center CRS Greensboro North Carolina
United States Univ. of Hawaii at Manoa, Leahi Hosp. Honolulu Hawaii
United States Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana
United States Methodist Hosp. of Indiana Indianapolis Indiana
United States USC CRS Los Angeles California
United States University of Minnesota, ACTU Minneapolis Minnesota
United States Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU New Orleans Louisiana
United States Beth Israel Med. Ctr. (Mt. Sinai) New York New York
United States Cornell University A2201 New York New York
United States NY Univ. HIV/AIDS CRS New York New York
United States NYU Med. Ctr., Dept. of Medicine New York New York
United States Stanford CRS Palo Alto California
United States Pitt CRS Pittsburgh Pennsylvania
United States Univ. of Rochester ACTG CRS Rochester New York
United States Washington U CRS Saint Louis Missouri
United States Ucsf Aids Crs San Francisco California
United States Santa Clara Valley Med. Ctr. San Jose California
United States San Mateo County AIDS Program San Mateo California
United States University of Washington AIDS CRS Seattle Washington
United States Harbor-UCLA Med. Ctr. CRS Torrance California

Sponsors (3)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome, Jacobus Pharmaceutical

Country where clinical trial is conducted

United States, 

References & Publications (3)

Rubin HR, Wu AW, Gutierrez M, Liriano O, Safrin S. Spanish translation of a functional status questionnaire for Pneumocystis carinii pneumonia. Int Conf AIDS. 1992 Jul 19-24;8(2):B178 (abstract no PoB 3549)

Safrin S, Finkelstein DM, Feinberg J, Frame P, Simpson G, Wu A, Cheung T, Soeiro R, Hojczyk P, Black JR. Comparison of three regimens for treatment of mild to moderate Pneumocystis carinii pneumonia in patients with AIDS. A double-blind, randomized, trial of oral trimethoprim-sulfamethoxazole, dapsone-trimethoprim, and clindamycin-primaquine. ACTG 108 Study Group. Ann Intern Med. 1996 May 1;124(9):792-802. — View Citation

Wu AW, Gray S, Brookmeyer R, Safrin S. Quality of life in a double-blind randomized trial of 3 oral regimens for mild-to-moderate Pneumocystis carinii pneumonia in AIDS (ACTG 108). Int Conf AIDS. 1996 Jul 7-12;11(1):229 (abstract no TuB112)

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