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

Juan A. Arnaiz104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Acquired Immune Deficiency Syndrome Virus

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes