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

• Sponsor: Juan A. Arnaiz (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02337322
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 56
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acquired Immune Deficiency Syndrome Virus	Drug: Dolutegravir; Drug: Darunavir/r	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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).
• Actual Study Start Date: Mar 31, 2015
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ABC+3TC+DTG Abacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen	Drug: Dolutegravir
Active Comparator: ABC+3TC+DRV/r Abacavir+lamivudine+ritonavir-boosted darunavir, QD	Drug: Darunavir/r; Other Names: Ritonavir-boosted Darunavir

Outcome Measures

Primary Outcome Measures

1. Median CD4 T cell count increase [48 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinic of Barcelona	Barcelona	BCN	Spain	08013

Sponsors and Collaborators

• Juan A. Arnaiz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona
• ClinicalTrials.gov Identifier: NCT02337322
• Other Study ID Numbers: Advanz-4
• First Posted: Jan 13, 2015
• Last Update Posted: Aug 3, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona: Acquired Immune Deficiency Syndrome Virus; HIV; HIV-1; Antiretroviral treatment; HIV Advanced Disease; AIDS; Dolutegravir; Darunavir
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Ritonavir; Darunavir; Dolutegravir

Study Results

No Results Posted as of Aug 3, 2018