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
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.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- 2002-06
Outcome
Missed primary endpoint
paper No clinically important or statistically significant differences were found among the four arms with regard to SBI or weight change over the 24-week period. PMID 10634196 ↗
paper the small differences among the arms in the primary and secondary endpoints do not support claims of efficacy for the measures studied. PMID 10634196 ↗
Publications
- Background Randall P. Low-dose oral alpha interferon study opens. NIAID AIDS Agenda. 1996 Jun:4-5.
- Background Low-dose oral alpha interferon trial closes. NIAID AIDS Agenda. 1997 Aug:10.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Interferon alfa-n1 | Protein / enzyme biologic | — | Oral |
| Subject | Interferon alfa-n3 | Protein / enzyme biologic | — | Oral |