NCT02337322

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).

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Juan A. Arnaiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Immune Deficiency Syndrome Virus

Interventions

Type	Name	Description
DRUG	Dolutegravir
DRUG	Darunavir/r

Timeline

• Start date: 2015-03-31
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2015-01-13
• Last updated: 2018-08-03

Locations

1 site across 1 country: Spain