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

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ClinicalTrials.gov Identifier: NCT02513147
Recruitment Status : Completed
First Posted : July 31, 2015
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
University Hospital, Ghent
IrsiCaixa
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV-1 Drug: Dolutegravir Drug: PI Drug: 2 NRTI Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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): 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
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02513147     History of Changes
Other Study ID Numbers: INDOOR
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Lopinavir
Darunavir
Atazanavir Sulfate
Fosamprenavir
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