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

This study is currently recruiting participants.

See

Contacts and Locations

Verified June 2016 by Juan A. Arnaiz, Hospital Clinic of Barcelona

Sponsor:

Information provided by (Responsible Party):

Juan A. Arnaiz, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT02337322

First received: January 9, 2015

Last updated: October 19, 2016

Last verified: June 2016

History of Changes

Purpose

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	Intervention	Phase
Acquired Immune Deficiency Syndrome Virus	Drug: Dolutegravir Drug: Darunavir/r	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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).

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Darunavir Darunavir ethanolate Dolutegravir Dolutegravir sodium

U.S. FDA Resources

Further study details as provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:

Primary Outcome Measures:

Median CD4 T cell count increase [ Time Frame: 48 weeks ]


Estimated Enrollment:	108
Study Start Date:	April 2015
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	January 9, 2015
Last Updated:	October 19, 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

ClinicalTrials.gov processed this record on June 23, 2017

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