AEGiS-13IAC: The effects of hydroxyurea or placebo combined with efavirenz, didanosine, and stavudine in treatment naive and experienced patients: preliminary 24 week results from the 3d study.

13th International AIDS Conference

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

The effects of hydroxyurea or placebo combined with efavirenz, didanosine, and stavudine in treatment naive and experienced patients: preliminary 24 week results from the 3d study.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrB603)

Murphy R, Katlama C, Autran B, Belsey E, Harris M, Montaner JS, Pollard R, Hellinger J, Squires K, Calvez V, Gulick R, Sommadossi J-P, Pavia A, Youle M, Schacker T, Berzins B, O'Gorman M, Johnson V, Landay A
R. Murphy, Northwestern University, 303 E. Superior Street, Room 828, Chicago, Illinois, 60611, United States, Tel.: +1 312 908 0949, Fax: +1 312 908 8281, E-mail: r-murphy@nwu.edu

BACKGROUND: Hydroxyurea (HU) has been shown to enhance the antiviral activity of nucleosides, particularly didanosine (ddI), as well as having potential immunologic effects. The study objectives were to evaluate the 48 week effects of HU on HIV RNA, CD4 count and lymphocyte subsets in patients (pts) taking a 3 drug non-PI antiviral regimen.

METHODS: 3D is an ongoing, international, multicenter, randomized, placebo-controlled 48 week trial of efavirenz (EFV) 600 mg qd + stavudine (d4T)40 mg bid + ddI 400 mg qd plus HU 600 mg bid or matching placebo (added to regimen at week 8). Eligible pts had CD4 >100 cells/uL, HIV RNA >500 c/ml, had never received HU or an NNRTI, were treatment naive or had less than 12 weeks prior treatment with ddI and/or d4T.

RESULTS: 100 naive pts with median baseline (BL) HIV RNA of 46,005 c/ml and CD4 371 cells/uL and 49 treatment experienced pts with median BL HIV RNA of 6,882 c/ml and CD4 337 cells/uL were enrolled. The 24 week data, available on 91/149 pts, show that 90% of the naive and 95% of the experienced pts had HIV RNA >500 c/ml. The mean increase in CD4 count was respectively 48 and 27 cells/uL. 42 pts reported a grade 3/4 toxicity: hyperamylasemia (9), peripheral neuropathy (7), neutropenia (6), CNS symptoms (6), hepatic transaminasemia (5), lipasemia (4), rash (2), pancreatitis (2), hepatitis (1); 16/42 stopped 1 or more study drugs. There were no clinical events. Immunologic and virologic studies are underway.

CONCLUSION: ddI/d4T/EFV + HU or placebo displays high viral efficacy with >90% pts suppressing HIV RNA to >500 c/ml at week 24. The long term effects of HU's role on proviral DNA, antiviral efficacy and immunologic function are being performed

Keywords: AEGIS, Stavudine, Didanosine, Oxazines, Hydroxyurea, CD4 Lymphocyte Count, HIV Infections, Drug Therapy, Combination, Antiretroviral Therapy, Highly Active, Placebos, CD4-Positive T-Lymphocytes, Case-Control Studies, efavirenz, Human, therapy, drug therapy
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WeOrB603