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

Juan A. Arnaiz

Status and phase: Unknown; Phase 4

Conditions: Acquired Immune Deficiency Syndrome Virus

Treatments: Drug: Dolutegravir; Drug: Darunavir/r

Study type: Interventional

Funder types: Other

Identifiers

NCT02337322

Advanz-4

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

ABC+3TC+DTG

Active Comparator group

Description:

Abacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen

Treatment:

Drug: Dolutegravir

ABC+3TC+DRV/r

Active Comparator group

Description:

Abacavir+lamivudine+ritonavir-boosted darunavir, QD

Treatment:

Drug: Darunavir/r