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

Immune Reconstitution in Severely Immunosuppressed Antiretroviral-naive HIV-1-Infected Patients (<100 CD4+ T Cells/μL) Taking Antiretroviral Regimens Based on Dolutegravir or Ritonavir-boosted Darunavir (the Advanz-4 Trial).

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.

Inclusion Criteria:

1. HIV patients > 18 years old who provide signed and dated informed consent.
2. Male and female.
3. Chronic HIV infection.
4. Antiretroviral naïve.
5. Confirmed CD4+ T cell count below 100 cells/mm3
6. HLA B5701 negative patients.

Exclusion Criteria:

1. Active opportunistic infections requiring parenteral treatment
2. Patients with cryptococcal meningitis treated with voriconazole
3. AIDS-defining cancers needing chemotherapy.
4. Female patients pregnant or breastfeeding.
5. Patients with documented history of allergy to sulfonamides.
6. Any contraindications to study drugs.