14th International AIDS Conference Barcelona, Spain — July 7-12, 2002

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. TuOrB1188

BACKGROUND: HAART regimens usually contain drugs from either one or two of the drug classes. A triple class HAART regimen may be associated with a better virological effect than traditional HAART, but may also lead to toxicity, drug interactions and more profound resistance. Comparative trials of using either two or all three drugs classes together are lacking.

METHODS: Randomised, controlled, open-label trial of 233 PI and NNRTI naïve HIV-infected patients allocated to a regimen of N/N (1250/200 mg bid; n =118) or R/S (400/400 mg bid; n =115) plus two NRTI's. Randomisation was completed in January 2001. The primary end point was plasma viral load (pVL) < 20 copies/mL after 48 weeks (missing value=failure). Patients remained under follow-up also in case of switches away from the randomised therapy.

RESULTS: At baseline, the median CD4 cell counts were 126 (5-95%: 10-460) (N/N) and 150 (12-430) (R/S) cells/mm³ and pVLs 5.0 (3.3-6.1) and 5.0 (3.3-5.9) log₁₀ copies/mL, resp. 102 (86.4 and 101 (87.8%), resp., were antiretroviral naïve. Within 48 weeks, 33.9% (N/N) and 44.3% (R/S) discontinued randomised therapy; p=0.10, of these 82.5% and 72.6% discontinued due to adverse events; p=0.49. At week 48, 66.4% and 51.8%, resp., had a pVL < 20 c/mL; p= 0.024. Median increases in the CD4 cell count were 185 (3-475) and 140 (-88-330) cells/mm³, resp.; p=0.14, and decreases in pVL expressed as area under the curve minus baseline were 2.95 (0.12-4.05) and 2.87 (0-3.89) log₁₀ copies/mL; p=0.10. No significant difference was observed with respect to clinical progression nor frequency of severe/life-threatening adverse events.

CONCLUSIONS: A regimen of N/N + 2NRTI's was well tolerated and had superior virological effect over a 48 week period compared with R/S + 2NRTI's. However, more extensive follow-up and comparisons with newer dual class regimens should be performed before this treatment can be recommended for routine usage.

Presenting author: Ole Kirk

1Dept Infect Dis, Hvidovre Hospital, Department of Infectious Diseases 144, Hvidovre University Hospital, Kettegaard Alle, 2650 Hvidovre, Denmark.

2Dept Infect Dis, Odense Hospital, Odense, Denmark.

3Dept Infect Dis, Aalborg Hospital, Aalborg, Denmar.

4Dept Infect Dis, Rigshospitalet, Copenhagen, Denmark.

5Dept Infect Dis, Skejby Hospital, Aarhus, Denmark.

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