AEGiS-11IAC: Prevention of recurrent genital herpes in HIV-infected males with a dual combination therapy: human leukocyte interferon-alpha in cream and oral zidovudine.

11th International AIDS Conference

Vancouver, British Columbia — July 7-12, 1996

Prevention of recurrent genital herpes in HIV-infected males with a dual combination therapy: human leukocyte interferon-alpha in cream and oral zidovudine.

Int Conf AIDS 1996 Jul 7-12; 11:442 (abstract no. Pub.A.1030)
Tanweer AS, Seyed AA, Seyed HA; Department of Clinical Physiology, Malmo University Hospital, University of Lund, Sweden. Fax: INT.+ 40-336254.

OBJECTIVE: The aim of this open study was to determine the frequency of recurrent genital herpes infections in HIV-infected patients, and to evaluate suppression, tolerance and safety of a dual combination therapy comprising human leukocyte interferon-alpha(2 x 106 IU/g) in cream and oral Zidovudine (250 mg).

METHODS: Twenty male, HIV-patients, revealed by polymerase chain reaction (PCR) and experiencing concurrent recurrent herpes simplex genitalis were selected and entered the study. Diagnosis of HSV types (1, 2) was assayed by culture and PCR. Subjects were 18-30 years of age (mean 23.6) and were harboring 88 lesions(mean 4.4). Besides 250 mg Zidovudin twice daily 3 times a week, patients received a 40-g tube containing human leukocyte interferon-alpha in cream (2 x 106 IU/g) with instructions on how to apply the medication on their lesions 3 times daily for five consecutive days (max. 15 topical applications, protocol limitation). Patients were examined after 24 hours of initial treatment, and thereafter 3 times a week. An entirely re-epitheliazed lesion (PCR-confirmed) with persistent resolution of erythema was considered as healed. Drug-related adverse effects or other laboratory abnormalities, if any, were recorded at each visit.

RESULTS: The study demonstrated significant clinical and biological tolerance, with no overlapping of antiretroviral toxicity. Human leukocyte interferon-alpha in cream healed 80% patients within a week with significantly shorter mean duration (2.1 days). Hemoglobin level, neutrophil and platelet counts were within normal limits. Of the 20 patients 75% complained of no drug-related adverse symptoms, with no dropouts. Five patients reported non-objective transitory increase in their body temperature (greater than 38 degrees C) with moderate headache and malaise. During follow-up (on monthly basis, after 4 weeks), 3 out of 16 healed patients, had a relapse after 21 months.

CONCLUSIONS: The findings indicated that leukocyte interferon-alpha(2 x 106IU/g) exhibited no risk of overlapping toxicity with Zidovudine, and with non-objective mild to moderate side effects, the regimen can be considered a safe and reliable treatment modality to heal HIV-infected, recurrent genital herpes male patients.

Keywords: AEGIS, Herpes Genitalis, Zidovudine, Interferon-alpha, Antiviral Agents, Administration, Topical, Interferon Inducers, Podophyllotoxin, Human, Male, ICA11

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PubA1030