Frissen PH, Weverling GJ; International Conference on AIDS.

Int Conf AIDS. 1992 Jul 19-24; 8: B184 (abstract no. PoB 3582).

University of Amsterdam, The Netherlands.

OBJECTIVE: To assess the efficacy and tolerance of ZDV + native IFN-alpha versus ZDV monotherapy. Zidovudine (ZDV) and interferon-alpha (IFN) show synergistic activity against HIV-1 and interfere with HIV replication at different levels. METHODS: Multicentre, randomised, controlled study. Study population: symptomatic HIV-1 infection (CDC group IV), CD4+ greater than or equal to 150 x 10(6)/l, Karnofsky score (KPF) greater than or equal to 60 and no signs of haematologic impairment. Intervention: ZDV 250 mg q12h + IFN 3 x 10(6) U s.c., 3 times/week, or ZDV 250 mg q6h. Forty subjects were enrolled. Clinical and laboratory evaluations were conducted at 4-weekly intervals. Follow-up was 36 weeks. RESULTS: Base line characteristics were similar for both groups (n = 20/group). Two subjects (ZDV) were excluded (protocol violation). One subject (ZDV) died after 8 weeks due to stroke. HIV-p24 antigen concentrations declined similarly in both groups. CD4+ T-cell counts tended to be higher in ZDV + IFN at 24 and 36 weeks. Percentual change from base line was significant at week 24 (p = 0.03). T-cell proliferative responses on Mab anti-CD3 stimulation improved temporarily in both groups. beta 2-microglobulin (B2M) levels remained unchanged in ZDV + IFN, whereas B2M only declined from week 0 to 24 in ZDV. Progression to AIDS (CDC IVD) occurred in one ZDV + IFN subject. No significant differences in body weight, KPS, and the incidence of HIV-related events between the groups was found. No serious adverse effects occurred in either of the groups. Fatigue, malaise, anorexia and low-grade fever were observed more frequently in ZDV + IFN. Protocoled treatment interruptions were recorded exclusively in ZDV + IFN. CONCLUSIONS: CD4+ T-cell counts are more sustained during ZDV + low dose native IFN-alpha than during ZDV therapy. Serious side effects did not occur. However, tolerance of ZDV + IFN might be slightly less than for ZDV.

Publication Types:

• Meeting Abstracts

Keywords:

• Acquired Immunodeficiency Syndrome
• Antigens, CD4
• CD4 Lymphocyte Count
• Demography
• Disease Progression
• HIV Core Protein p24
• HIV Infections
• HIV-1
• Humans
• Interferon-alpha
• United States
• Zidovudine
• immunology
• methods

Other ID:

• 92401317

UI: 102199030

From Meeting Abstracts