Clinical trial NCT00000844: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Adjuvants, Immunologic
Administration, Oral
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Interferon-alpha
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 560
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: King - Drew Med Ctr
state: California
city: Redwood City
country: United States
facility: AIDS Community Research Consortium
state: California
city: New Haven
country: United States
facility: Yale Univ / New Haven
state: Connecticut
city: Wilmington
country: United States
facility: Med Ctr of Delaware / Wilmington Hosp
state: Delaware
city: Washington
country: United States
facility: Georgetown Univ Med Ctr
state: District of Columbia
city: Washington
country: United States
facility: Abundant Life Clinic Foundation
state: District of Columbia
city: Washington
country: United States
facility: Howard Univ Hosp
state: District of Columbia
city: Detroit
country: United States
facility: Henry Ford Hosp
state: Michigan
city: Minneapolis
country: United States
facility: Univ of Minnesota Hosp
state: Minnesota
city: Brooklyn
country: United States
facility: SUNY / Health Sciences Ctr at Brooklyn
state: New York
city: New York
country: United States
facility: Dr Barbara Justice
state: New York
city: New York
country: United States
facility: Harlem AIDS Treatment Group / Harlem Hosp Ctr
state: New York
city: Valhalla
country: United States
facility: New York Med College / Westchester County Med Ctr
state: New York
city: Philadelphia
country: United States
facility: Univ of Pennsylvania Med Ctr
state: Pennsylvania
city: Nashville
country: United States
facility: Meharry Med College
state: Tennessee
Study officials:
name: Alston B
role: STUDY_CHAIR
name: Standiford H
role: STUDY_CHAIR
name: Kumi J
role: STUDY_CHAIR
name: Greaves W
role: STUDY_CHAIR
References:
citation: Randall P. Low-dose oral alpha interferon study opens. NIAID AIDS Agenda. 1996 Jun:4-5.
citation: Low-dose oral alpha interferon trial closes. NIAID AIDS Agenda. 1997 Aug:10.
citation: 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). Division of AIDS Treatment Research Initiative (DATRI) 022 Study Group. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):348-57. doi: 10.1097/00126334-199912010-00005.