AEGiS-13IAC: Hydroxychloroquine combined with hydroxyurea and didanosine: a new economical triple therapy.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Hydroxychloroquine combined with hydroxyurea and didanosine: a new economical triple therapy.

Int Conf AIDS 2000 Jul 9-14; 13:18 (abstract no.. LbOr8)

Aboulhab J, Karim F, Verghese I, Leo YS, Chapman C, Paton N;;; Tan Tock Seng Hospital, Singapore.

BACKGROUND: Hydroxychloroquine/chloroquine are inexpensive drugs with anti-HIV activity in-vivo, and synergistic activity with hydroxyurea and didanosine in-vitro. We performed a prospective open-label pilot study to evaluate the safety, tolerability and efficacy of the combination of hydroxychloroquine,hydroxyurea and didanosine.

METHODS: We studied anti-retroviral naive patients with viral load (VL)<100,000 copies/ml, CD4 count > 150 cells/mm³ and no opportunistic infection within the previous 6 months. Patients received the combination of hydroxychloroquine (200mg bid),hydroxyurea (500mg bid)and didanosine (125/200mg bid) for 24 weeks. The study was conducted from September 1999 to May 2000.

RESULTS: 23 eligible patients were recruited and 6 were withdrawn due to non-compliance. 17 completed the study protocol (median age 34, baseline VL 21,848 copies/ml, CD4 count 242cells/mm³). At week 12, 5 patients (29%)had undetectable VL (<400 copies/ml). The median VL reduction was 1.43 log₁₀copies/ml (p<0.001)and the median rise in CD4 count was 28 cells/mm³. At week 24, 6 patients (35%) had undetectable VL. The VL reduction was 1.22 log₁₀copies/ml (p<0.001) and the rise in CD4 count was 66cells/mm³ (P<0.05). The treatment was well tolerated. There were 2 adverse events of grade 3 severity considered possibly or probably related to study medication (neutropenia and increased amylase) and 2 serious adverse events not related to study medication. None of the patients had evidence of retinopathy after 24 weeks.

CONCLUSION: The combination of hydroxychloroquine, hydroxyurea and didanosine is safe and well tolerated. The modest reduction in VL may be of value in patients with low VL at baseline. The relatively low cost makes this new triple combination an attractive regimen in resource-limited settings.

Keywords: AEGIS, Didanosine, Hydroxyurea, CD4 Lymphocyte Count, Hydroxychloroquine, Anti-HIV Agents, Viral Load, HIV Infections, Drug Therapy, Combination, Antiretroviral Therapy, Highly Active, HIV, HIV Protease Inhibitors, HIV-1 Reverse Transcriptase, Prospective Studies, Human, therapy, drug therapy, AIDS
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