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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000844

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

560

Expected to finish

2002-06-01

Last updated by the study team

2021-11-03

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.