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

Acquired Immune Deficiency Syndrome Virus Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02337322
• Other study ID #: Advanz-4
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 31, 2015
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome Virus
• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Dolutegravir

• Darunavir/r

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona	BCN

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median CD4 T cell count increase		48 weeks