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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

NCT00000802 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2021-11-04

No results posted yet for this study

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.

Conditions

  • Pneumonia, Pneumocystis Carinii
  • HIV Infections

Interventions

DRUG

Atovaquone

DRUG

Dapsone

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • El-Sadr W

  • Luskin-Hawk R

  • Murphy R

Study Design

Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
1997-07-31

Countries

  • United States
  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000802 on ClinicalTrials.gov