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Low-dose zidovudine in combination with either acyclovir or lymphoblastoid interferon-alpha in asymptomatic HIV-infected patients: A pilot study

Antiretrovirale Kombinationstherapie von asymptomatischen HIV Infizierten mit Zidovudine und Interferon-alpha oder Zidovudine und Aciclovir: Eine Pilotstudie

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Summary

The antiretroviral activity, tolerance and toxicity of two different antiviral drug combinations were assessed and compared in a randomized, crossover pilot study in 16 HIV-1 p24 antigenaemic subjects with asymptomatic HIV infection. Oral zidovudine 250 mg twice daily was combined with either oral acyclovir 800 mg twice daily or lymphoblastoid interferon-alpha 1.5×106 IU administered subcutaneously three times weekly. The 12-week treatment period was followed by a 4-week washout period and a further 12-week crossover phase. During the entire treatment period a decline in p24 antigen was observed in all patients. No significant differences were found between the two treatment regimens. No patient showed clinical progression of HIV infection. Three patients were withdrawn from the study, one due to serious anaemia and two due to severe clinical adverse events. Long-term efficacy and tolerance data in asymptomatic HIV-infected patients with these regimens would be valuable.

Zusammenfassung

In einer randomisierten cross-over Studie wurden 16 asymptomatische HIV Infizierte, die ein positives HIV-1 p24 Antigen aufwiesen, mit zwei verschiedenen antiviralen Kombinationstherapien behandelt und die antiretrovirale Aktivität, Verträglichkeit und Toxizität miteinander verglichen. Zidovudin, 2 × 250 mg täglich peroral, wurde entweder kombiniert mit Aciclovir, 2×800 mg täglich peroral, oder mit lymphoblastoid Interferon-alpha, 1.5×106 IU 3 × wöchentlich subkutan. Eine 12-wöchige Therapiephase war gefolgt von einer 4- wöchigen Auswaschperiode und anschließend einer weiteren 12-wöchigen cross- over Therapiephase. Ein Abfall des HIV-1 p24 Antigen wurde bei allen Patienten während beiden Behandlungsphasen beobachtet. Zwischen den beiden Kombinationstherapien konnte kein Unterschied gefunden werden. Eine Progression der HIV Infektion trat bei keinem Patienten auf. Bei drei Patienten mußte die Medikation wegen Nebenwirkungen vorzeitig gestoppt werden. Ob asymptomatische HIV Infizierte von anti-viralen Kombinationstherapien profitieren, soll in Langzeitstudien evaluiert werden.

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Authors and Affiliations

  1. Abteilung für Infektionskrankheiten, Departement für Innere Medizin, Universitätsspital, CH-8091, Zürich, Switzerland

    R. Weber,  A. Bonetti,  J. Jost,  M. W. Vogt,  W. Siegenthaler &  R. Lüthy

  2. The Wellcome Research Laboratories, Langley Court, South Eden Park Road, BR3 3BS, Beckenham, Kent, UK

    B. Spacey M. D.

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  1. R. Weber
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Weber, R., Bonetti, A., Jost, J. et al. Low-dose zidovudine in combination with either acyclovir or lymphoblastoid interferon-alpha in asymptomatic HIV-infected patients: A pilot study. Infection 19, 395–400 (1991). https://doi.org/10.1007/BF01726447

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