7th Conference on Retroviruses and Opportunistic Infections San Francisco, CA - January 30 -February 4, 2000

Conf Retroviruses Opportunistic Infect 2000 Jan 30-Feb 2; 7:78 (abstract no. 19)

J. M. Molina, E. Angelini, L. Cotte, J. M. Lang, P. Morlat, C. Rancinan, T. May, V. Journot, F. Raffi, B. Jarrousse, M. Grappin, G. Lepeu, G. Chene, And The Albi Study Group
St-Louis Hosp, Paris; INSERM U. 330, Bordeaux; Hotel Dieu, Lyon; Strasbourg Hosp., Strasbourg; St-Andre Hosp., Bordeaux; Brabois Hosp., Nancy; Nantes Hosp., Nantes; Avicenne Hosp., Bobigny; Bocage Hosp., Dijon; H. Duffaut Hosp., Avignon; Agence Natl. de Recherches sur le Sida (ANRS), Paris, France

BACKGROUND: Whether the use of nucleoside analogue reverse transcriptase inhibitors (NRTI) is associated with an increased risk of a lipodystrophic syndrom remains controversial. We describe results obtained from the long-term follow-up of a randomized trial comparing various NRTI-containing regimens.

METHODS: 151 previously untreated HIV-1 infected patients with baseline mean CD4+ cell counts 404/mm³ and mean plasma HIV RNA 4.5 log₁₀ copies/ml were randomly assigned to 6 months of open-labeled d4T plus ddI, ZDV plus 3TC or d4T+ddI followed by ZDV+3TC (alternating group). At 6 months, the combination of d4T+ddI reduced plasma HIV-1 RNA and increased CD4+ cell counts more effectively than did the other combinations. At Month 30 (M30) of the long-term follow-up, investigators were asked whether patients presented physical manifestations of fat redistribution.

RESULTS: Data were available for 83 patients (55%): 25 randomized in the d4T-ddI group, 29 in the ZDV-3TC group and 30 in the alternating group. Switch to a protease inhibitor (PI) had occurred in 16%, 55% and 27% in each arm respectively and to a non nucleoside analogue (NNRTI) in 28%, 38% and 40% respectively. Overall, 35% presented at least one manifestation of lipodystrophy (LD) (95%CI: 25%-46%). In 42 patients continuing to receive only NRTI, it was 37% (95%CI :22-55%). Prevalence of LD was 52%, 28% and 27% in each arm respectively (p=0.09). The prevalence of lipoatrophy was 44%, 21% and 23%, respectively (p=0.12). The prevalence of truncular adiposity was 28%, 10% and 13%, respectively (p=0.19). In patients with LD at M30 compared to those without, there was a higher mean duration of exposure to d4T: 19 vs 13 months (p=0.01) and a higher mean duration of ddI: 18.5 vs 11.5 months (p=0.01). Duration of exposure to ZDV (10 vs 15 months), 3TC (10 vs 16 months), PI (5 vs 5 months), or NNRTI (3 vs 3 months) did not differ significantly.

CONCLUSION: In the ALBI trial, overall prevalence of LD at M30 was 35%. It was twice higher in patients randomized in the d4T-ddI arm than in patients randomized in the other arms, although patients in other arms were switched more frequently to a PI-containing regimen.

Keywords: AEGIS, Reverse Transcriptase Inhibitors, Lipodystrophy, Stavudine, Lamivudine, Didanosine, Zidovudine, CD4 Lymphocyte Count, Anti-HIV Agents, HIV-1, HIV Protease Inhibitors, Clinical Trials, HIV Infections, Diabetes Mellitus, Lipoatrophic, HIV, Prevalence, Human, AIDS

2000-01-30
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