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).
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2015
CompletedFirst Posted
Study publicly available on registry
January 13, 2015
CompletedStudy Start
First participant enrolled
March 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 3, 2018
August 1, 2018
4.7 years
January 9, 2015
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median CD4 T cell count increase
48 weeks
Study Arms (2)
ABC+3TC+DTG
ACTIVE COMPARATORAbacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen
ABC+3TC+DRV/r
ACTIVE COMPARATORAbacavir+lamivudine+ritonavir-boosted darunavir, QD
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Juan A. Arnaizlead
Study Sites (1)
Hospital Clinic of Barcelona
Barcelona, BCN, 08013, Spain
Related Publications (1)
Miro JM, Torres F, Manzardo C, Bonfill E, Curran A, Domingo P, Podzamczer D, Paredes R, Force L, Falco V, Gutierrez M, Saumoy M, Castelli A, Inciarte A, Rovira C, Cruceta A, Hurtado C, Climent N, Lozano F, Plana M; Advanz-4 investigators. Immune reconstitution in very advanced HIV patients treated with dolutegravir vs. darunavir-based triple antiretroviral therapy: the Advanz-4 randomized clinical trial. Clin Microbiol Infect. 2026 Jan;32(1):169-176. doi: 10.1016/j.cmi.2025.09.026. Epub 2025 Oct 11.
PMID: 41083105DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 9, 2015
First Posted
January 13, 2015
Study Start
March 31, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
August 3, 2018
Record last verified: 2018-08