HIV-1
Conditions
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).
Interventions
DRUGDolutegravir
DRUGPI
(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
DRUG2 NRTI
Sponsors
University Hospital, Ghent
IrsiCaixa
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Spain
Outcome results
None listed