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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| ClinicalTrials.gov Identifier: NCT00000802 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : November 4, 2021
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Pneumonia, Pneumocystis Carinii HIV Infections | Drug: Atovaquone Drug: Dapsone | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 700 participants |
| 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 |
| Actual Study Completion Date : | July 1997 |
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000802
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| Study Chair: | El-Sadr W | ||
| Study Chair: | Luskin-Hawk R | ||
| Study Chair: | Murphy R |
| ClinicalTrials.gov Identifier: | NCT00000802 |
| Other Study ID Numbers: |
ACTG 277 CPCRA 034 11253 ( Registry Identifier: DAIDS-ES ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | November 4, 2021 |
| Last Verified: | October 2021 |
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Pneumonia, Pneumocystis carinii Dapsone Antifungal Agents Acquired Immunodeficiency Syndrome atovaquone |
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Pneumonia Pneumonia, Pneumocystis Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Lung Diseases, Fungal Mycoses Bacterial Infections and Mycoses Pneumocystis Infections Dapsone |
Atovaquone Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Anti-Bacterial Agents |