Immune Recovery in Advanced , ARV-naïve, HIV-1-infected Individuals Taking Dolutegravir or Ritonavir-boosted Darunavir

Summary

There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of 2 different combinations of antiretroviral therapy given once a day (QD): abacavir plus lamivudine plus either dolutegravir, or darunavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.

Timeline

Start

2015-03-31

Primary completion

2019-12

Completion

2019-12

Publications

• Miro JM, Torres F, Manzardo C, Bonfill E, Curran A, Domingo P, Podzamczer D, Paredes R, Force L, Falco V, Gutierrez M, Saumoy M, Castelli A, Inciarte A, Rovira C, Cruceta A, Hurtado C, Climent N, Lozano F, Plana M; Advanz-4 investigators. Immune reconstitution in very advanced HIV patients treated with dolutegravir vs. darunavir-based triple antiretroviral therapy: the Advanz-4 randomized clinical trial. Clin Microbiol Infect. 2026 Jan;32(1):169-176. doi: 10.1016/j.cmi.2025.09.026. Epub 2025 Oct 11.

Drugs

Indications