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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Juan A. Arnaiz
• Treatments: Darunavir; Dolutegravir; Ritonavir

Criteria

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.