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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Atovaquone Drug: Dapsone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official 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 |
| Estimated Enrollment: | 700 |
| Study Completion Date: | July 1997 |
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| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations
Show 44 Study Locations| Study Chair: | El-Sadr W | |
| Study Chair: | Luskin-Hawk R | |
| Study Chair: | Murphy R |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00000802 History of Changes |
| Other Study ID Numbers: | ACTG 277, CPCRA 034, 11253 |
| Study First Received: | November 2, 1999 |
| Last Updated: | April 2, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Pneumonia, Pneumocystis carinii Dapsone Antifungal Agents Acquired Immunodeficiency Syndrome atovaquone |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lung Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Dapsone Trimethoprim Atovaquone Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013