A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3

HIV Infections Clinical Trial

Official title:

A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000844
• Other study ID #: DATRI 022
• Secondary ID: 11727
• Status: Completed
• Phase: N/A
• Est. completion date: June 2002

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 evaluate the effects of three preparations of low-dose oral interferon alpha (i.e., Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate differences in response to oral interferon alpha according to gender, race/ethnicity, and use of antiretrovirals.

Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.

Description:

Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.

Patients are randomized to receive 6 months of Alferon LDO alone, Alferon with Veldona, Alferon with Ferimmune, or three placebos, with follow-up visits monthly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: June 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Patients must have:

• Symptomatic HIV infection.

• CD4 count 50 - 350 cells/mm3.

Prior Medication:

Allowed:

• Prior antiretrovirals (dose must be stable for at least 6 weeks prior to study entry).

• Maintenance therapy for a chronic condition.

Exclusion Criteria

Patients with the following prior condition are excluded:

• Change in antiretroviral therapy within past 6 weeks.

Prior Medication:

Excluded:

• Oral IFN-alpha or other immune-based therapy within the past month.

• Therapy for any acute disease within the past week.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Interferon alfa-n3

• Interferon alfa-n1

Locations

Country	Name	City	State
United States	SUNY / Health Sciences Ctr at Brooklyn	Brooklyn	New York
United States	Henry Ford Hosp	Detroit	Michigan
United States	King - Drew Med Ctr	Los Angeles	California
United States	Univ of Minnesota Hosp	Minneapolis	Minnesota
United States	Meharry Med College	Nashville	Tennessee
United States	Yale Univ / New Haven	New Haven	Connecticut
United States	Dr Barbara Justice	New York	New York
United States	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York
United States	Univ of Pennsylvania Med Ctr	Philadelphia	Pennsylvania
United States	AIDS Community Research Consortium	Redwood City	California
United States	New York Med College / Westchester County Med Ctr	Valhalla	New York
United States	Abundant Life Clinic Foundation	Washington	District of Columbia
United States	Georgetown Univ Med Ctr	Washington	District of Columbia
United States	Howard Univ Hosp	Washington	District of Columbia
United States	Med Ctr of Delaware / Wilmington Hosp	Wilmington	Delaware

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

Alston B, Ellenberg JH, Standiford HC, Muth K, Martinez A, Greaves W, Kumi J. A multicenter, randomized, controlled trial of three preparations of low-dose oral alpha-interferon in HIV-infected patients with CD4+ counts between 50 and 350 cells/mm(3). Div — View Citation

Low-dose oral alpha interferon trial closes. NIAID AIDS Agenda. 1997 Aug:10. — View Citation

Randall P. Low-dose oral alpha interferon study opens. NIAID AIDS Agenda. 1996 Jun:4-5. — View Citation