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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000802 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety Study |
| 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 |
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:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Contacts and Locations
Show 89 Study Locations| Study Chair: | El-Sadr W | |
| Study Chair: | Luskin-Hawk R | |
| Study Chair: | Murphy R |
More Information
| Study ID Numbers: | ACTG 277, CPCRA 034 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000802 History of Changes |
| Health Authority: | United States: Federal Government |
|
Pneumonia, Pneumocystis carinii Dapsone Antifungal Agents Acquired Immunodeficiency Syndrome atovaquone |
|
Sexually Transmitted Diseases, Viral Trimethoprim Folate Vitamin B9 Pneumonia, Pneumocystis Mycoses Antimalarials Anti-Bacterial Agents Respiratory Tract Infections Respiratory Tract Diseases Antifungal Agents Dapsone Retroviridae Infections Lung Diseases, Fungal |
Acquired Immunodeficiency Syndrome Anti-Infective Agents, Urinary Folic Acid Antagonists Folinic Acid Immunologic Deficiency Syndromes Virus Diseases Folic Acid Pneumocystis Infections Atovaquone HIV Infections Lung Diseases Sexually Transmitted Diseases Pneumonia |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Trimethoprim Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Renal Agents Infection Anti-Bacterial Agents Pneumonia, Pneumocystis Mycoses Antimalarials Antiparasitic Agents Respiratory Tract Diseases Respiratory Tract Infections |
Therapeutic Uses Dapsone Retroviridae Infections Lung Diseases, Fungal RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Anti-Infective Agents, Urinary Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Pneumocystis Infections Atovaquone |
