A prospective randomized trial on abacavir/lamivudine plus darunavir/ritonavir or raltegravir in HIV-positive drug-naive patients with CD4<200 cells/uL (the PRADAR study).

ABSTRACT:

Background

Very few data are available on treatment in HIV Late presenter population that still represents a clinical challenge.

Methods

Prospective, multicenter, randomized open-label, 2 arm, phase-3 trial comparing the 48-week virological response of two different regimens: abacavir/lamivudine + darunavir/r vs abacavir/lamivudine + raltegravir in antiretroviral naive with CD4+ counts < 200/mm3 and a viral load (VL)<500,000 copies/mL. The primary Endpoint was the proportion of patients with undetectable viremia (VL<50 copies/mL) after 48 weeks. The planned sample size for this trial was 350 patients.

Results

In 3 years, 53 patients were screened and 46 enrolled: 22 randomized to raltegravir and 24 to darunavir/r; 7 patients were excluded, 4 because of a VL >500,000 c

SUBMITTER: Mussini C 

PROVIDER: S-EPMC6764686 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature