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

Phase 4

• Conditions: Acquired Immune Deficiency Syndrome Virus
• Interventions: Drug: Darunavir/r; Drug: Dolutegravir

• Registration Number: NCT02337322
• Lead Sponsor: Juan A. Arnaiz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-13
• Study Start: 2015-03-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABC+3TC+DRV/r	Darunavir/r	Abacavir+lamivudine+ritonavir-boosted darunavir, QD
ABC+3TC+DTG	Dolutegravir	Abacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen

Primary Outcome Measures

Name	Time	Method
Median CD4 T cell count increase	48 weeks

Trial Locations

Locations (1)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, BCN, Spain