HIV Reservoir Dynamics After Switching To Dolutegravir in Patients on a PI/r Based Regimen. A Phase IV Open Randomized Trial

Phase 1

• Conditions: HIV-1 Infection; MedDRA version: 17.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-004331-39-ES
• Lead Sponsor: Fundació Vall Hebron Institut de Recerca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-25
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Adult patients infected with HIV-1
- HIV-RNA <50 copies / mL for ? 1 year with stable regimen of ART (? 3 months) based on a IP / r 2 AN
- CD4+ lymphocytes > 200 / mm3
- Voluntary signature of informed consent
- A woman, may be eligible to enter and participate in the study if:

a. no-childbearing potential, defined as post-menopausal (12 months of spontaneous amenorrhea and ? 45 years of age) or physically unable to get pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy.
b. You are of a child-bearing 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 penile-vaginal intercourse from 2 weeks before administration of the IP, over the course of the study and for at least 2 weeks after discontinuation of all study drugs;
- Double barrier method (male condom / spermicide, condom male / diaphragm, diaphragm / spermicide);
- Any intrauterine device (IUD) with published data that show that the expected rate of failure is <1% per year (not all IUDs meet this criterion);
- Confirmed male sterilization before to entry of the female subject in the study, and that this man is the only sexual partner for the woman;
- Hormonal Contraception Approved
- Any other method with published data that show that the expected rate of failure is <1% per year.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Prior virologic failure with a integrase inhibitor
- AIDS defining disease in the last 48 weeks
- Glomerular filtration rate <50 mL / min, estimated by the formula CKD-EP*I
- ALT ?5 times the upper limit of normal (ULN) or ALT ?3 times ULN and total bilirubin ?1,5 ULN (with> 35% of direct bilirubin) and / or unstable liver disease (presence of ascites, hepatic encephalopathy, hypoalbuminemia, presence of esophageal varices or persistent jaundice) or biliary disorders known excluding Gilbert's syndrome or asymptomatic urolithiasis)
- Hepatitis B positive (HBsAg +) or need of treatment HCV during the study.
- Subjects with severe hepatic damage (Child Pugh Class C).
- Patients unable to understand the study protocol or any other condition that in the investigator's opinion would compromise the protocol compliance.
- Pregnant or nursing women
- History or presence of allergy to any of the study drugs or their components.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the HIV reservoir dynamics after the change of IP / r by dolutegravir in HIV-1 infected patients that they maintain suppressed the viral load (HIV RNA <50 copies / ml) with AN ART 2 and 1 IP / r;Secondary Objective: To study the evolution of immune activation and inflammatory markers in both treatment groups;Primary end point(s): Changes in mean CD4 + T 2LTR in peripheral blood collected at weeks 1, 2, 4, 12 and 24 of the study lymphocytes compared to day 0;Timepoint(s) of evaluation of this end point: Weeks 1, 2, 4, 12 and 24