Exploratory, open-label, randomized clinical trial to assess the efficacy of first-line dual vs. triple antiretroviral therapy (art) in hiv-1 reservoir and in peripheral compartments in hiv-infected patients.

Phase 1

Conditions: HIV infection
Therapeutic area: Diseases [C] - Virus Diseases [C02]
MedDRA version: 20.1Level: LLTClassification code 10008919Term: Chronic HIV infectionSystem Organ Class: 100000004862

Registration Number: EUCTR2019-002733-10-ES

Lead Sponsor: FUNDACIÓ LLUITA CONTRA LA SIDA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 44

Inclusion Criteria

1. Age =18 years.
2. Documented HIV-1 infection (confirmed by a NAT/PCR test).
3. Naïve to cART (Pre-exposure prophylaxis with FTC/TDF or TAF/FTC or post-exposure prophylaxis will be allowed if more than 4 weeks before the screening visit).
4. Willing and able to be adherent to antiretroviral therapy for the duration of the study.
5. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
6. In the opinion of the principal investigator or designee, the participant has understood the information provided and capable of giving written informed consent.
7. If female in fertile age and heterosexually active; using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner*) from 14 days prior to the first study product administration until at least 12 weeks after the last study product administration; all female participants must be willing to undergo urine pregnancy tests at time points specified in the Schedule of Procedures.
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

1. Exposure to any antiretroviral drug within the 4 weeks prior to the screening visit.
2. HIV-1 RNA in plasma >500,000 copies/mL.
3. Active AIDS-defining illness within the prior 4 weeks.
4. Chronic hepatitis B (positive HBsAg).
5. Chronic hepatitis C (positive IgG HCV confirmed by positive HCV RNA in plasma).
6. Estimated glomerular filtration rate (eGFR) <50 mL/min.
7. Advance liver function impairment (Child-Pugh C).
8. Use of systemic chemotherapy within the 12 months before the screening visit.
9. Use of systemic corticosteroids during more than 7 consecutive days within the 3 months before the screening visit.
10. Concomitant treatment with co-medications with known drug-drug interactions with study drugs.
11. History or clinical manifestations of any physical or psychiatric disorder which could impair the subject’s ability to complete the study.
12. Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study.
13. In women, pregnancy or breastfeeding.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method