To compare the safety and efficacy of two dosage regimens (daily and thrice-weekly) of sulfamethoxazole/trimethoprim (SMX/TMP; TMS) in the prevention of Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients. Previous tests have shown that SMX/TMP given daily is effective in preventing recurrence of PCP and may be effective in preventing PCP in patients who have never developed it. Because SMX/TMP can cause side effects, this study will attempt to determine the safest and most effective dose of this combination.

Condition	Treatment or Intervention	Phase
Pneumonia, Pneumocystis carinii HIV Infections	Drug: Sulfamethoxazole-Trimethoprim	Phase III

Further Study Details: 

Expected Total Enrollment:  2500

Previous tests have shown that SMX/TMP given daily is effective in preventing recurrence of PCP and may be effective in preventing PCP in patients who have never developed it. Because SMX/TMP can cause side effects, this study will attempt to determine the safest and most effective dose of this combination.

Patients receive SMX/TMP orally on a daily or thrice-weekly basis. Patients are clinically evaluated every 4 months. Patients on daily SMX/TMP who develop a drug-related toxicity may be switched to thrice-weekly SMX/TMP. Duration of follow-up is 12 months.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

• HIV infection.
• CD4 count <= 200 cells/mm3 OR a history of prior PCP.
• No active pneumocystosis. Patients or their guardians must sign informed consent. Pregnant patients are eligible at the clinician's discretion. Patients who do not meet required laboratory values may be eligible at the discretion of the clinician.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms and conditions are excluded:

• Known treatment-limiting reaction to sulfonamides or trimethoprim.

Concurrent Medication: Excluded:

• Other PCP prophylaxis or medication with anti-PCP activity.

California
      Community Consortium of San Francisco, San Francisco,  California,  94110,  United States
      Stanford Univ School of Medicine, Stanford,  California,  943055107,  United States
Colorado
      Denver CPCRA / Denver Public Hlth, Denver,  Colorado,  802044507,  United States
Delaware
      Wilmington Hosp / Med Ctr of Delaware, Wilmington,  Delaware,  19899,  United States
District of Columbia
      Veterans Administration Med Ctr / Regional AIDS Program, Washington,  District of Columbia,  20422,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
Illinois
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States
Louisiana
      Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans,  Louisiana,  70112,  United States
Maryland
      Univ of Maryland at Baltimore, Baltimore,  Maryland,  21201,  United States
      Baltimore Trials, Baltimore,  Maryland,  21201,  United States
Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States
      Comprehensive AIDS Alliance of Detroit, Detroit,  Michigan,  48201,  United States
New Jersey
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States
      Southern New Jersey AIDS Cln Trials / Dept of Med, Camden,  New Jersey,  08103,  United States
New Mexico
      Univ Hosp / HIV - ID Clinic, Albuquerque,  New Mexico,  87131,  United States
      Partners Research, Albuquerque,  New Mexico,  871315271,  United States
New York
      Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York,  New York,  10037,  United States
      Bronx Lebanon Hosp Ctr, Bronx,  New York,  10456,  United States
      Clinical Directors Network of Region II, New York,  New York,  10011,  United States
      Addiction Research and Treatment Corp, Brooklyn,  New York,  11201,  United States
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  972109951,  United States
Pennsylvania
      Philadelphia FIGHT, Philadelphia,  Pennsylvania,  19107,  United States
Virginia
      Richmond AIDS Consortium, Richmond,  Virginia,  23298,  United States
Washington
      Univ of Washington / Pacific Med Ctr, Seattle,  Washington,  98144,  United States

Study chairs or principal investigators

W El-Sadr,  Study Chair
R Luskin-Hawk,  Study Chair

Study ID Numbers:  CPCRA 006
Record last reviewed:  August 2004
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000748
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08