AEGiS-05CROI: AVANTI 3. A randomised, double blind, comparative trial to evaluate the efficacy, safety and tolerance of AZT/3TC vs AZT/3TC/nelfinavir in anti-retroviral naïve patients.

5th Conference on Retroviruses and Opportunistic Infections

Chicago, IL - February 1-5, 1998

AVANTI 3. A RANDOMISED, DOUBLE BLIND, COMPARATIVE TRIAL TO EVALUATE THE EFFICACY, SAFETY AND TOLERANCE OF AZT/3TC VS AZT/3TC/NELFINAVIR IN ANTI-RETROVIRAL NAÏVE PATIENTS.

Conf Retroviruses Opportunistic Infect 1998 Feb 1-5; 5th:80 (abstract no. 8)

Clumeck N
Hospital St. Pierre, Belgium.

AVANTI 3 is the third in a series of trials designed to investigate a number of multi-drug combinations in HIV+, anti-retroviral naïve patients with CD4 counts between 150 and 500 cells/µ. 102 patients from Europe, Canada and Australia were randomised to receive either AZT (200mg tid)/3TC (150mg bid) (n=51) or AZT/3TC/nelfinavir (750mg tic) (n=51) for 52 weeks. Patients were assessed regularly for viral load, CD4 count and safety. The median baseline viral load (log₁₀ copies/ml) was 4.8 for the AZT/3TC group and 5.0 for the AZT/3TC/nelfinavir group, while the median baseline CD4 count was 287 × 10⁶ cells/l and 279 × 10⁶ cells/1 respectively. Preliminary Area Under the Curve Minus Baseline (0-28 weeks) data for viral load are now available, together with numbers of patients below 500 copies/ml at week 28. These are presented below.

	AZT/3TC	AZT/3TC/NFV	p
AUCMB Viral load (log₁₀) Median decrease over 28 weeks	-0.98	-1.85	<0.001
Viral load Patients below 500 copies/ml at 28 weeks	7/40 (18%)	34/41 (83%)	–

CONCLUSIONS: Both treatment groups demonstrated improvement in viral load over the 28 week period and AUCMB analysis demonstrated a statistically significant reduction in viral load over same timeframe for AZT/3TC/nelfinavir as compared to AZT/3TC. Further data on CD4 and safety will also be presented.

Keywords: AEGIS, Lamivudine, Zidovudine, Nelfinavir, Viral Load, CD4 Lymphocyte Count, Anti-HIV Agents, Reverse Transcriptase Inhibitors, HIV Infections, HIV Protease Inhibitors, HIV, Double-Blind Method, Canada, Europe, Australia, Human, AIDS

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1998-02-01
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