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

Primary Purpose

Acquired Immune Deficiency Syndrome Virus

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Dolutegravir
Darunavir/r
Sponsored by
Juan A. Arnaiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Immune Deficiency Syndrome Virus focused on measuring Acquired Immune Deficiency Syndrome Virus, HIV, HIV-1, Antiretroviral treatment, HIV Advanced Disease, AIDS, Dolutegravir, Darunavir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Clinic of Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ABC+3TC+DTG

ABC+3TC+DRV/r

Arm Description

Abacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen

Abacavir+lamivudine+ritonavir-boosted darunavir, QD

Outcomes

Primary Outcome Measures

Median CD4 T cell count increase

Secondary Outcome Measures

Full Information

First Posted
January 9, 2015
Last Updated
August 2, 2018
Sponsor
Juan A. Arnaiz
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1. Study Identification

Unique Protocol Identification Number
NCT02337322
Brief Title
Immune Recovery in Advanced , ARV-naïve, HIV-1-infected Individuals Taking Dolutegravir or Ritonavir-boosted Darunavir
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).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 31, 2015 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan A. Arnaiz

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immune Deficiency Syndrome Virus
Keywords
Acquired Immune Deficiency Syndrome Virus, HIV, HIV-1, Antiretroviral treatment, HIV Advanced Disease, AIDS, Dolutegravir, Darunavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABC+3TC+DTG
Arm Type
Active Comparator
Arm Description
Abacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen
Arm Title
ABC+3TC+DRV/r
Arm Type
Active Comparator
Arm Description
Abacavir+lamivudine+ritonavir-boosted darunavir, QD
Intervention Type
Drug
Intervention Name(s)
Dolutegravir
Intervention Type
Drug
Intervention Name(s)
Darunavir/r
Other Intervention Name(s)
Ritonavir-boosted Darunavir
Primary Outcome Measure Information:
Title
Median CD4 T cell count increase
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV patients > 18 years old who provide signed and dated informed consent. Male and female. Chronic HIV infection. Antiretroviral naïve. Confirmed CD4+ T cell count below 100 cells/mm3 HLA B5701 negative patients. Exclusion Criteria: Active opportunistic infections requiring parenteral treatment Patients with cryptococcal meningitis treated with voriconazole AIDS-defining cancers needing chemotherapy. Female patients pregnant or breastfeeding. Patients with documented history of allergy to sulfonamides. Any contraindications to study drugs.
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
State/Province
BCN
ZIP/Postal Code
08013
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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