AEGiS-13IAC: The Atlantic Study: a randomized, open-label trial comparing two protease inhibitor (pi)-sparing anti-retroviral strategies versus a standard pi-containing regimen, final 48 week data.

13th International AIDS Conference

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

The Atlantic Study: a randomized, open-label trial comparing two protease inhibitor (pi)-sparing anti-retroviral strategies versus a standard pi-containing regimen, final 48 week data.

Int Conf AIDS 2000 Jul 9-14; 13:43 (abstract no.. LbPeB7046)

Squires K;;; University of Alabama, Division of Infectious Diseases, Birmingham, AL 35294-0006. Fax: +1-205-934-6398, E-mail: kathleen@byrd1917.his.uab.edu.

BACKGROUND: The Atlantic Study was designed to compare the safety, activity and durability of d4T/ddI/3TC, d4T/ddI/nevirapine (NVP), and d4T/ddI/indinavir (IDV).

METHODS: In a multicenter, open-label study, HIV- I infected ARV-naive patients (pts) with >200 CD4 cells/mm³ and plasma HIV-1 RNA >500 c/mL (Roche Amplicor Ultrasensitive) were randomized to one of these three treatments. Standard daily dosages of d4T, 3TC and IDV were used, with ddl (400 mg) and NVP (400 mg) being dosed QD.

RESULTS: 298 pts were enrolled with a median baseline CD4 cell count of 406 (IQR 322-528) cells/mm³ and a median plasma HIV-1 RNA of 4.2 (IQR 3.8-4.8) log₁₀ c1mL, being well balanced across arms. In the intention to treat (ITT) analysis after 48 weeks, 49% had less than 50 cp/mL in the IDV arm, 49% in NVP, and 40% in 3TC (IDV vs. NVP: p=0.95; IDV vs. 3TC: p=0.21; NVP vs. 3TC: p=0.20). The results in an as treated (AT) analysis were 91%, 82%, 67%, resp. (p=0.16; 0.002; and 0.068, resp.). Among pts with a baseline HIV-1 RNA>58,519 c1m) (upper quartile range), more IDV pts had HIV-1 RNA <50 c/mL after 48 weeks compared to NVP and 3TC, although this difference was not stat. significant (ITT: 48%, 28% and 26%, resp., p=0.18; AT: 80%, 56% and 42%, resp., p=0.08). No difference was found with 500 HIV-1 RNA c/mL as the cutoff (AT: 80%, 78% and 79%, resp., p=0.99). The regimens were similarly well-tolerated and no differences were found in discontinuations due to toxicities.

CONCLUSIONS: These data indicate that first-line ARV regimens containing d4T/ddI/IDV, d4T/ddI/NVP, or d4T/ddI/3TC display similar potent ARV activity in an ITT analysis and are well tolerated. There was a nonstatistically significant trend among pts with a higher baseline plasma HIV-1 RNA: more Ins in the IDV-containing arm had a plasma HIV-1 RNA <50 c/mL (but not <500 c/mL).

Keywords: AEGIS, Stavudine, Lamivudine, Indinavir, Didanosine, CD4 Lymphocyte Count, HIV Infections, Nevirapine, Protease Inhibitors, HIV Protease Inhibitors, HIV-1, Retroviridae, CD4-Positive T-Lymphocytes, Human, AIDS
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