PMID- 10710206 OWN - NLM STAT- MEDLINE DCOM- 20000420 LR - 20061115 IS - 0889-2229 (Print) IS - 0889-2229 (Linking) VI - 16 IP - 3 DP - 2000 Feb 10 TI - A randomized trial of interferon alpha therapy for HIV type 1 infection. PG - 183-90 AB - The immunologic and virologic efficacy and safety of interferon a (IFN-alpha) administered in combination with zidovudine (ZDV) and zalcitabine (ddC) was evaluated in HIV-infected subjects with CD4+ cell counts between 300 and 500 cells/ml and no more than 14 weeks of prior antiretroviral therapy. A total of 256 subjects enrolled in an open-label, randomized controlled trial. Subjects were randomized equally into treatment groups. All subjects received ZDV and ddC, while half also receive IFN-alpha (3 MU subcutaneously every 24 hr). At 48 weeks the median average area under the curve minus baseline (AAUCMB) for plasma HIV-1 RNA for the two-drug group was -0.68 versus -0.75 log10 copies/ml for the IFN-alpha group (p = 0.046). Mean HIV-1 RNA changes from baseline to 48 weeks for these groups were -0.65 and -1.12 log10 copies/ml, respectively (p = 0.010). The median AAUCMB for CD4+ cell count for the two-drug group was 28 versus -1 cells/mm3 for the IFN-alpha group (p = 0.011). Neutropenia, anemia, and drug intolerance were more common in the IFN-alpha group. This study demonstrates that IFN-alpha inhibits HIV-1 replication but attenuates the CD4+ cell response to dual therapy with ZDV and ddC. FAU - Haas, D W AU - Haas DW AD - Vanderbilt University Medical Center, Nashville, Tennessee 37212, USA. david.w.haas@vanderbilt.edu FAU - Lavelle, J AU - Lavelle J FAU - Nadler, J P AU - Nadler JP FAU - Greenberg, S B AU - Greenberg SB FAU - Frame, P AU - Frame P FAU - Mustafa, N AU - Mustafa N FAU - St Clair, M AU - St Clair M FAU - McKinnis, R AU - McKinnis R FAU - Dix, L AU - Dix L FAU - Elkins, M AU - Elkins M FAU - Rooney, J AU - Rooney J LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - AIDS Res Hum Retroviruses JT - AIDS research and human retroviruses JID - 8709376 RN - 0 (Anti-HIV Agents) RN - 0 (HIV Core Protein p24) RN - 0 (Interferon-alpha) RN - 0 (RNA, Viral) SB - IM MH - Adolescent MH - Adult MH - Anti-HIV Agents/adverse effects/*therapeutic use MH - CD4 Lymphocyte Count MH - Drug Resistance, Microbial MH - Female MH - HIV Core Protein p24/blood MH - HIV Infections/blood/*drug therapy/immunology/virology MH - *HIV-1 MH - Humans MH - Interferon-alpha/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - RNA, Viral/blood EDAT- 2000/03/10 09:00 MHDA- 2000/04/25 09:00 CRDT- 2000/03/10 09:00 PHST- 2000/03/10 09:00 [pubmed] PHST- 2000/04/25 09:00 [medline] PHST- 2000/03/10 09:00 [entrez] AID - 10.1089/088922200309278 [doi] PST - ppublish SO - AIDS Res Hum Retroviruses. 2000 Feb 10;16(3):183-90. doi: 10.1089/088922200309278.