--- title: A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides nct_id: NCT00000802 overall_status: COMPLETED phase: PHASE3 sponsor: National Institute of Allergy and Infectious Diseases (NIAID) study_type: INTERVENTIONAL primary_condition: Pneumonia, Pneumocystis Carinii countries: United States, Tanzania canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00000802.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00000802" ct_last_update_post_date: 2021-11-04 last_seen_at: "2026-05-12T06:24:56.185Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides **NCT ID:** [NCT00000802](https://clinicaltrials.gov/study/NCT00000802) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 700 - **Lead Sponsor:** National Institute of Allergy and Infectious Diseases (NIAID) - **Conditions:** Pneumonia, Pneumocystis Carinii, HIV Infections - **Completion Date:** 1997-07 - **CT.gov Last Update:** 2021-11-04 ## Brief Summary To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts \<= 200 cells/mm3 or \<= 15 percent of the total lymphocyte count who are intolerant to trimethoprim and/or sulfonamides. Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents. ## Detailed Description Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents. Patients are randomized to receive either dapsone or atovaquone daily, with follow-up at the clinic every 4 months. ## Eligibility - **Minimum age:** 13 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria Concurrent Medication: Strongly recommended: * Pyrimethamine (50 mg) and folinic acid (15 mg) weekly in patients receiving dapsone who have CD4 count \< 100 cells/mm3 and are toxoplasmosis seropositive. Patients must have: * Working diagnosis of HIV infection. * CD4 count \<= 200 cells/mm3 or \<= 15 percent of total lymphocyte count at any time in the past OR a history of PCP. * History of intolerance of trimethoprim and/or sulfonamides that required permanent discontinuation. NOTE: * Pregnant patients are eligible at the clinician's discretion. Prior Medication: Allowed: * Prior PCP prophylaxis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Active pneumocystosis. Concurrent Medication: Excluded: * PCP prophylaxis (other than study drug) or any medication with potential anti-PCP activity. Patients with the following prior conditions are excluded: * Known treatment-limiting reaction to dapsone or atovaquone. ``` ## Interventions - **Atovaquone** (DRUG) - **Dapsone** (DRUG) ## Locations (44) - Alabama Therapeutics CRS, Birmingham, Alabama, United States - USC CRS, Los Angeles, California, United States - Stanford CRS, Palo Alto, California, United States - Ucsd, Avrc Crs, San Diego, California, 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 - Harbor-UCLA Med. Ctr. CRS, Torrance, California, United States - University of Colorado Hospital CRS, Aurora, Colorado, United States - Howard University Hosp., Div. of Infectious Diseases, ACTU, Washington D.C., District of Columbia, United States - Univ. of Miami AIDS CRS, Miami, Florida, United States - Emory Univ. Hemophilia Program Office, Atlanta, Georgia, United States - Queens Med. Ctr., Honolulu, Hawaii, United States - Univ. of Hawaii at Manoa, Leahi Hosp., Honolulu, Hawaii, United States - Northwestern University CRS, Chicago, Illinois, United States - Cook County Hosp. CORE Ctr., Chicago, Illinois, United States - Rush Univ. Med. Ctr. ACTG CRS, Chicago, Illinois, United States - Weiss Memorial Hosp., Chicago, Illinois, United States - Indiana Univ. School of Medicine, Infectious Disease Research Clinic, Indianapolis, Indiana, United States - Univ. of Iowa Healthcare, Div. of Infectious Diseases, Iowa City, Iowa, United States - Johns Hopkins Adult AIDS CRS, Baltimore, Maryland, United States - Bmc Actg Crs, Boston, Massachusetts, United States - Beth Israel Deaconess - East Campus A0102 CRS, Boston, Massachusetts, United States - Massachusetts General Hospital ACTG CRS, Boston, Massachusetts, United States - Hennepin County Med. Ctr., Div. of Infectious Diseases, Minneapolis, Minnesota, United States - University of Minnesota, ACTU, Minneapolis, Minnesota, United States - St. Louis ConnectCare, Infectious Diseases Clinic, St Louis, Missouri, United States - Washington U CRS, St Louis, Missouri, United States - Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr., Omaha, Nebraska, United States - SUNY - Buffalo, Erie County Medical Ctr., Buffalo, New York, United States - Beth Israel Med. Ctr. (Mt. Sinai), New York, New York, United States - NY Univ. HIV/AIDS CRS, New York, New York, United States - Univ. of Rochester ACTG CRS, Rochester, New York, United States - Unc Aids Crs, Chapel Hill, North Carolina, United States - Carolinas HealthCare System, Carolinas Med. Ctr., Charlotte, North Carolina, United States - Regional Center for Infectious Disease, Wendover Medical Center CRS, Greensboro, North Carolina, United States - Wake County Health and Human Services CRS, Raleigh, North Carolina, United States - Univ. of Cincinnati CRS, Cincinnati, Ohio, United States - Case CRS, Cleveland, Ohio, United States - MetroHealth CRS, Cleveland, Ohio, United States - The Ohio State Univ. AIDS CRS, Columbus, Ohio, United States - Hosp. of the Univ. of Pennsylvania CRS, Philadelphia, Pennsylvania, United States - University of Washington AIDS CRS, Seattle, Washington, United States - Mbeya Med. Research Program, Mbeya Referral Hosp. CRS, Mbeya, Tanzania ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.alabama therapeutics crs|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.usc crs|los angeles|california|united states` — added _(2026-05-12)_ - `locations.stanford crs|palo alto|california|united states` — added _(2026-05-12)_ - `locations.ucsd, avrc crs|san diego|california|united states` — added _(2026-05-12)_ - `locations.ucsf aids crs|san francisco|california|united states` — added _(2026-05-12)_ - `locations.santa clara valley med. ctr.|san jose|california|united states` — added _(2026-05-12)_ - `locations.san mateo county aids program|san mateo|california|united states` — added _(2026-05-12)_ - `locations.harbor-ucla med. ctr. crs|torrance|california|united states` — added _(2026-05-12)_ - `locations.university of colorado hospital crs|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.howard university hosp., div. of infectious diseases, actu|washington d.c.|district of columbia|united states` — added _(2026-05-12)_ - `locations.univ. of miami aids crs|miami|florida|united states` — added _(2026-05-12)_ - `locations.emory univ. hemophilia program office|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.queens med. ctr.|honolulu|hawaii|united states` — added _(2026-05-12)_ - `locations.univ. of hawaii at manoa, leahi hosp.|honolulu|hawaii|united states` — added _(2026-05-12)_ - `locations.northwestern university crs|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.cook county hosp. core ctr.|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.rush univ. med. ctr. actg crs|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.weiss memorial hosp.|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.indiana univ. school of medicine, infectious disease research clinic|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.univ. of iowa healthcare, div. of infectious diseases|iowa city|iowa|united states` — added _(2026-05-12)_ - `locations.johns hopkins adult aids crs|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.bmc actg crs|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.beth israel deaconess - east campus a0102 crs|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.massachusetts general hospital actg crs|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.hennepin county med. ctr., div. of infectious diseases|minneapolis|minnesota|united states` — added _(2026-05-12)_ - `locations.university of minnesota, actu|minneapolis|minnesota|united states` — added _(2026-05-12)_ - `locations.st. louis connectcare, infectious diseases clinic|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.washington u crs|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.univ. of nebraska med. ctr., durham outpatient ctr.|omaha|nebraska|united states` — added _(2026-05-12)_ - `locations.suny - buffalo, erie county medical ctr.|buffalo|new york|united states` — added _(2026-05-12)_ - `locations.beth israel med. ctr. (mt. sinai)|new york|new york|united states` — added _(2026-05-12)_ - `locations.ny univ. hiv/aids crs|new york|new york|united states` — added _(2026-05-12)_ - `locations.univ. of rochester actg crs|rochester|new york|united states` — added _(2026-05-12)_ - `locations.unc aids crs|chapel hill|north carolina|united states` — added _(2026-05-12)_ - `locations.carolinas healthcare system, carolinas med. ctr.|charlotte|north carolina|united states` — added _(2026-05-12)_ - `locations.regional center for infectious disease, wendover medical center crs|greensboro|north carolina|united states` — added _(2026-05-12)_ - `locations.wake county health and human services crs|raleigh|north carolina|united states` — added _(2026-05-12)_ - `locations.univ. of cincinnati crs|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.case crs|cleveland|ohio|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00000802.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00000802* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*