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

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ClinicalTrials.gov Identifier: NCT02337322
Recruitment Status : Recruiting
First Posted : January 13, 2015
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated Enrollment : 108 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).
Study Start Date : April 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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 Name: Ritonavir-boosted Darunavir


Outcome Measures

Primary Outcome Measures :
  1. Median CD4 T cell count increase [ Time Frame: 48 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337322


Contacts
Contact: Jose Miro, MD, PhD +34932775586 jmmiro@ub.es

Locations
Spain
Hospital Clinic of Barcelona Recruiting
Barcelona, BCN, Spain, 08013
Contact: Jose Miro, PhD    +34932275586    jmmiro@ub.edu   
Sponsors and Collaborators
Juan A. Arnaiz
More Information

Responsible Party: Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02337322     History of Changes
Other Study ID Numbers: Advanz-4
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: June 2016

Keywords provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:
Acquired Immune Deficiency Syndrome Virus
HIV
HIV-1
Antiretroviral treatment
HIV Advanced Disease
AIDS
Dolutegravir
Darunavir

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ritonavir
Darunavir
Dolutegravir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors