A Phase I/II Open Label Study To Evaluate the Antiviral Potential of Combination Low-Dose Therapy With Zidovudine and Interferon-Alpha 2A in Patients With Symptomatic HIV Disease

Summary

To evaluate the anti-HIV effect of single agent versus combination therapy with zidovudine (AZT) and interferon alfa-2a (IFN-A2a), as measured by p24 protein expression, viral growth and infectivity in patients with symptomatic HIV disease. To assess the safety of low dose schedules of AZT and IFN-A2a, alone and in combination, as measured by neutrophil counts and hepatic transaminase levels. To evaluate the comparative effects of single agent versus combination therapy with AZT and IFN-A2a on CD4 cell counts and skin test reactivity. AZT is known to be an effective treatment for HIV infection. However, patients may develop reactions to AZT when it is administered for long periods of time. Combining AZT with another drug at lower doses might reduce toxicity in patients and prevent the development of drug resistant strains. IFN-A2a can reduce the growth of HIV in test tube experiments and recent studies have shown that when AZT and IFN-A2a are used together they reduce the growth of HIV more effectively than when either drug is used alone. This study will examine the effectiveness and safety of these drugs when they are given together and compare these results with the effectiveness and safety of the drugs when they are used alone.

Timeline

Start

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Primary completion

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Completion

1993-11

Publications

• Background Zucker ML, Huberman KT, Hirschman SZ, Mildvan D. Stability of HIV-1 p24 antigen upon prolonged storage at -70 degrees C. The ACTG 068 Collaborative Team. Int Conf AIDS. 1992 Jul 19-24;8(3):44 (abstract no PuA 6203)
• Background Mildvan D, Bassiakos Y. Zidovudine (ZDV) and interferon-alpha 2a (IFN): ongoing assessment of synergy and tolerance in early ARC patients, ACTG 068. The ACTG 068 Collaborative Group. Int Conf AIDS. 1992 Jul 19-24;8(2):B184 (abstract no PoB 3586)
• Background Mildvan D, Ruprecht R, Krown S, Pettinelli C. Methodological issues in AIDS clinical trials. Application of the combination index method in the design of a clinical antiretroviral trial: ACTG 068. J Acquir Immune Defic Syndr (1988). 1990;3 Suppl 2:S111-3 discussion S114-9. No abstract available.
• Background Mildvan D, Bassiakos Y, Zucker ML, Hyslop N Jr, Krown SE, Sacks HS, Zachary J, Paredes J, Fessel WJ, Rhame F, Kramer F, Fischl MA, Poiesz B, Wood K, Ruprecht RM, Kim J, Grossberg SE, Kasdan P, Berge P, Marshak A, Pettinelli C. Synergy, activity and tolerability of zidovudine and interferon-alpha in patients with symptomatic HIV-1 infection: AIDS Clincal Trial Group 068. Antivir Ther. 1996 Apr;1(2):77-88.

Drugs

Indications