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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000771
• Other study ID #: ACTG 192
• Secondary ID: 11167
• Status: Completed
• Phase: Phase 2
• Est. completion date: September 1996

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 1996
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria Concurrent Medication:

Allowed:

• Antiretroviral therapy.
• Macrolides for disseminated Mycobacterium avium.
• Atovaquone for toxoplasmosis.
• Other antimicrobials for concurrent infections.
• Lomotil, Imodium, or deodorized opium tincture in a standardized regimen for diarrhea.

Patients must have:

• Advanced HIV disease.
• Diarrhea presumptively caused by Cryptosporidia. Exclusion Criteria Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Hypersensitivity to aminoglycosides.
• Inability to swallow capsules.
• Active infection due to other enteric pathogens. Previous diagnosis of CMV or MAC infection permitted if patient is currently stabilized on a therapeutic regimen (clarithromycin up to 500 mg bid or azithromycin up to 600 mg daily).
• Other known causes for diarrhea (e.g., malabsorption syndrome, gastrointestinal Kaposi's sarcoma). Concurrent Medication:

Excluded during the first 9 weeks of study:

• Agents with putative anticryptosporidial activity (such as spiramycin, diclazuril, letrazuril, or bovine colostrum).
• Octreotide acetate (Sandostatin).
• Antidiarrheals other than those specifically allowed.
• Clarithromycin if initiated at 500 mg or higher or azithromycin if initiated at 600 mg or higher. Prior Medication:

Excluded:

• Paromomycin at > 1 g/day for >= 14 days prior to study entry.

Excluded within 14 days prior to study entry:

• Agents with putative anticryptosporidial activity (such as spiramycin, diclazuril, letrazuril, or bovine colostrum), with the exception of macrolides that are permitted for other indications.
• Octreotide acetate (Sandostatin).

Related Conditions & MeSH terms

• Cryptosporidiosis
• HIV Infections

Intervention

Drug:
• Paromomycin sulfate

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico-AIDS CRS	San Juan
United States	SUNY - Buffalo, Erie County Medical Ctr.	Buffalo	New York
United States	Northwestern University CRS	Chicago	Illinois
United States	Rush Univ. Med. Ctr. ACTG CRS	Chicago	Illinois
United States	Weiss Memorial Hosp.	Chicago	Illinois
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	Indiana Univ. School of Medicine, Infectious Disease Research Clinic	Indianapolis	Indiana
United States	Methodist Hosp. of Indiana	Indianapolis	Indiana
United States	USC CRS	Los Angeles	California
United States	Univ. of Miami AIDS CRS	Miami	Florida
United States	Cornell University A2201	New York	New York
United States	NY Univ. HIV/AIDS CRS	New York	New York
United States	Washington U CRS	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (2)

Hewitt RG, Yiannoutsos CT, Carey J, Geiseler PJ, Soave R, Rosenberg R, Vazquez GJ, Wheat J, Fass RJ, Higgs ES, Antoninjevic Z, Walawander AL, Flanigan T, Bender J. A double-blind, placebo-controlled trial of paromomycin (par) for the treatment of cryptosporidiosis (cs) in patients with advanced HIV disease and CD4 counts under 150 (ACTG 192). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:65 (abstract no 4)

Hewitt RG, Yiannoutsos CT, Higgs ES, Carey JT, Geiseler PJ, Soave R, Rosenberg R, Vazquez GJ, Wheat LJ, Fass RJ, Antoninievic Z, Walawander AL, Flanigan TP, Bender JF. Paromomycin: no more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection. AIDS Clinical Trial Group. Clin Infect Dis. 2000 Oct;31(4):1084-92. Epub 2000 Oct 25. — View Citation