A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3

Phase 2

Completed

• Conditions: Cryptosporidiosis; HIV Infections

• Registration Number: NCT00000771
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To determine the effectiveness of oral paromomycin sulfate for 21 days compared to placebo in the treatment of cryptosporidiosis in patients with HIV infection. To evaluate the safety of oral paromomycin at two different doses. To explore whether paromomycin administered over a longer period provides additional benefit.

In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.

Detailed Description

In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.

Patients are randomized to receive either placebo or paromomycin for 3 weeks. After the initial double-blind phase, all patients receive open-label paromomycin for 3 weeks. Following 6 weeks of therapy, patients who do not achieve a complete response receive a higher dose of paromomycin for an additional 3 weeks, while complete responders continue receiving the original dose for an additional 3 weeks. Complete or partial responders after 9 weeks may receive 16 additional weeks of optional maintenance therapy at the dose at which their response was achieved. Treatment continues for up to 25 weeks total. Patients are followed at weeks 1, 3, 4, 6, 7, and 9, and then at 2-4 week intervals.

Study Timeline

• Study Completion: 1996-09
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (15)

Puerto Rico-AIDS CRS; 🇵🇷 San Juan, Puerto Rico

USC CRS; 🇺🇸 Los Angeles, California, United States

Univ. of Miami AIDS CRS; 🇺🇸 Miami, Florida, United States

Rush Univ. Med. Ctr. ACTG CRS; 🇺🇸 Chicago, Illinois, United States

Northwestern University CRS; 🇺🇸 Chicago, Illinois, United States

Weiss Memorial Hosp.; 🇺🇸 Chicago, Illinois, United States

Indiana Univ. School of Medicine, Infectious Disease Research Clinic; 🇺🇸 Indianapolis, Indiana, United States

Methodist Hosp. of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Washington U CRS; 🇺🇸 Saint Louis, Missouri, United States

SUNY - Buffalo, Erie County Medical Ctr.; 🇺🇸 Buffalo, New York, United States

NY Univ. HIV/AIDS CRS; 🇺🇸 New York, New York, United States

Cornell University A2201; 🇺🇸 New York, New York, United States

Univ. of Cincinnati CRS; 🇺🇸 Cincinnati, Ohio, United States

Case CRS; 🇺🇸 Cleveland, Ohio, United States

The Ohio State Univ. AIDS CRS; 🇺🇸 Columbus, Ohio, United States