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

HIV-1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513147
• Other study ID #: INDOOR
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2015
• Last updated: June 13, 2017
• Start date: June 2015
• Est. completion date: November 2016

Study information

• Verified date: June 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV-1

Intervention

Drug:
• Dolutegravir

• 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
• 2 NRTI

• 2 NRTI

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	IrsiCaixa, University Hospital, Ghent

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 week
Primary	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		2 weeks
Primary	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		4 weeks
Primary	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		12 weeks
Primary	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		24 weeks