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HIV Reservoir Dynamics After Switching to Dolutegravir in Patients on a PI and 2 NRTI Based Regimen

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University Hospital, Ghent
IrsiCaixa
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT02513147
First received: July 28, 2015
Last updated: June 6, 2016
Last verified: June 2016
  Purpose
The purpose of this study is to assess changes in viral reservoir after changing IP/r to dolutegravir in HIV-1 infected patients maintaining undetectable viral load on Antiretroviral Therapy (ART).

Condition Intervention Phase
HIV-1
Drug: Dolutegravir
Drug: PI
Drug: 2 NRTI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HIV Reservoir Dynamics After Switching to Dolutegravir in Patients With Two NRTI and a Protease Inhibitor Based Regimen. A Phase IV Open Randomized Trial

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Changes in mean of Long Terminal repeat (2LTR) in lymphocytes T Cluster of Differentiation 4+ (CD4 +) in peripheral blood obtained at week 1 of the study compared to day 0 [ Time Frame: 1 week ]
  • Changes in mean of Long Terminal repeat (2LTR) in lymphocytes T Cluster of Differentiation 4+ (CD4 +) in peripheral blood obtained at week 2 of the study compared to day 0 [ Time Frame: 2 weeks ]
  • Changes in mean of Long Terminal repeat (2LTR) in lymphocytes T Cluster of Differentiation 4+ (CD4 +) in peripheral blood obtained at week 4 of the study compared to day 0 [ Time Frame: 4 weeks ]
  • Changes in mean of Long Terminal repeat (2LTR) in lymphocytes T Cluster of Differentiation 4+ (CD4 +) in peripheral blood obtained at week 12 of the study compared to day 0 [ Time Frame: 12 weeks ]
  • Changes in mean of Long Terminal repeat (2LTR) in lymphocytes T Cluster of Differentiation 4+ (CD4 +) in peripheral blood obtained at week 24 of the study compared to day 0 [ Time Frame: 24 weeks ]

Enrollment: 44
Study Start Date: June 2015
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 NRTI+ Dolutegravir
22 patients will be treated with 2 NRTI+Dolutegravir 50 mg during 24 weeks
Drug: Dolutegravir Drug: 2 NRTI
Active Comparator: 2 NRTI + PI
22 patients will be treated with 2 NRTI + PI during 24 weeks
Drug: PI
(Fosamprenavir, atazanavir, lopinavir or darunavir) boosted with 100 mg of ritonavir, or atazanavir (400 mg / d) not boosted with ritonavir,if the 2 NRTIs are abacavir + Lamivudine
Other Name: Fosamprenavir, atazanavir, lopinavir or darunavir
Drug: 2 NRTI
Other Name: 2NRTI

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients infected with HIV-1
  • HIV RNA <50 copies / mL for ≥ 1 year with stable ART regimen (≥ 3 months) based on 2 NRTI and PI (Fosamprenavir, atazanavir, lopinavir or darunavir) boosted with 100 mg of ritonavir, or atazanavir (400 mg / d) not boosted with ritonavir, if the 2 NRTIs are abacavir + Lamivudine
  • CD4 + lymphocytes > 200 / mm3
  • Signature of voluntary informed consent
  • A woman may be eligible to enter and participate in the study if:

    1. No reproductive potential-defined as post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of getting pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy.
    2. It is in childbearing age with a negative pregnancy test on the day of screening and on Day 1 and agrees to use one of the following contraceptive methods to prevent pregnancy:

      • Complete abstinence from penis-vaginal from 2 weeks prior to administration of investigational product, throughout the study, and for at least 2 weeks after discontinuation of all study drugs;
      • Double barrier method (male / spermicidal condom, male condom / diaphragm, diaphragm / spermicide);
      • Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion)
      • Male sterilization confirmed before the entry of the female subject in the study, and that this man is the only sexual partner for women
      • Approved hormonal contraception
      • Any other method with published data show that the expected failure rate is <1% per year.

Exclusion Criteria:

  • Prior virologic failure with an integrase inhibitor
  • Acquired Immune Deficiency Syndrome (AIDS)-defining illness in the last 48 weeks
  • Glomerular filtration rate <50 mL / min, estimated by Chronic Kidney Disease Epidemiology (CKD-EPI) formula
  • Alanine aminotransferase (ALT) ≥5 times the Upper Limit Normal (ULN) or ALT ≥3 X ULN and total bilirubin ≥1,5 ULN (with> 35% direct bilirubin) and / or unstable liver disease (with the presence of ascites, hepatic encephalopathy, hypoalbuminemia, esophageal varices or persistent jaundice) or known biliary disorders excluded Gilbert syndrome or asymptomatic lithiasis) .
  • Positive for hepatitis B (HBsAg +) or need for Hepatitis C Virus (HCV) treatment during the study .
  • Subjects with severe hepatic impairment (Child Pugh Class C).
  • Patients unable to understand the study protocol or any other condition that in the investigator's opinion could jeopardize compliance with the protocol
  • Pregnant or breast-feeding
  • History or presence of allergy to any of the study drugs or their components
  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: NCT02513147

Locations
Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
University Hospital, Ghent
IrsiCaixa
  More Information

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02513147     History of Changes
Other Study ID Numbers: INDOOR
Study First Received: July 28, 2015
Last Updated: June 6, 2016

Additional relevant MeSH terms:
Fosamprenavir
Lopinavir
Darunavir
Atazanavir Sulfate
Dolutegravir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 25, 2017