Overview

A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS

Status:
Completed

Trial end date:
1994-09-01

Target enrollment:

Participant gender:

Summary

To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.

Phase:

Phase 3

Details

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators:

Glaxo Wellcome
Jacobus Pharmaceutical

Treatments:

Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Dapsone
Primaquine
Sulfamethoxazole
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination