Effectiveness of a dual therapy based on dolutegravir plus lamivudine on reduction of the viral reservoir, immune recovery and immune activation compared with a triple antiretroviral therapy based on dolutegravir plus tenofovir alafenamide/emtricitabine in patients with HIV infection without prior treatment.

Phase 1

• Conditions: Adult patients with HIV infection without previous treatment; MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: LLTClassification code 10020160Term: HIV diseaseSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-000800-14-ES
• Lead Sponsor: Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-11
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

?Treatment-naïve HIV-1-infected patients = 18 years of age.
?Plasma HIV-1 RNA >5000 and <500.000 copies/ml.
?T lymphocyte CD4+ count in peripheral blood >200/µl.
?Patients of childbearing age should consent to use a highly effective contraceptive method from 15 days before the time of inclusion of the study until 30 days after the end of it. It is considered a highly effective method:
oComplete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of Investigational Product, throughout the study, and for at least 2 weeks after discontinuation of all study medications;
oAny intrauterine device with published data showing that the expected failure rate is <1% per year (not all intrauterine devices meet this criterion)
oMale partner sterilization confirmed prior to the female subject’s entry into the study, and this male is the sole partner for that subject.
oApproved hormonal contraception.
oAny other method with published data showing that the expected failure rate is <1% per year.
?Signed written informed consent prior to inclusion.
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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

?Acute HIV infection
?T lymphocyte CD4+ count in peripheral blood = 200/µl
?Active opportunistic infection.
?Pregnancy at inclusion or during the follow-up
?Active hepatitis C and/or B virus co-infection.
?ALT = 5 times the ULN, or ALT = 3xULN and bilirubin = 1.5xULN (with >35% direct bilirubin).
?Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones).
?Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
?Current or past disease that requires the use subsidiary of treatment with corticosteroids, immunomodulatory agents, interferon or chemotherapeutic agents.
?Any laboratory abnormality grade 3 or 4 according to the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (Annex 3)
?Concomitant use of drugs with potential major interactions with the prescribed drugs according the respective full prescribing information.
?Estimated creatinine clearance <50ml/min.
?History or presence of allergy to the study drugs or their components

Study & Design

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