Triple vs. Double Therapy in naïves HIV-Infected Patients

NCT ID: NCT04295460

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2023-03-31

Brief Summary

The objective of this study is to clarify whether if starting antiretroviral treatment based on dual therapy (DTG + 3TC) could provide less control of residual HIV replication and, therefore, a detriment on immune activation and inflammation compared to starting with triple therapy, and could worsen the patients' long-term prognosis. For this purpose, the investigator has designed a randomized clinical trial where will assess the immunological recovery (CD4+/CD8+), immune activation, proliferation, senescence and apoptosis in T lymphocytes CD4+ and CD8+ cells by flow cytometry, the immune activation of monocytes/ macrophages and plasma concentrations of various inflammatory mediators by ELISAS, and the thymic function, the cellular reservoir of HIV and the degree of HIV DNA transcription by digital dropped PCR.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dual Therapy

Dolutegravir plus lamivudine

Group Type: EXPERIMENTAL

Randomize

Intervention Type: DRUG

Randomize to naive-treatment HIV-infected patients to receive dual o triple therapy as initial antiretroviral treatment

Triple Therapy

Dolutegravir plus TAF/FTC

Group Type: ACTIVE_COMPARATOR

Randomize

Intervention Type: DRUG

Randomize to naive-treatment HIV-infected patients to receive dual o triple therapy as initial antiretroviral treatment

Interventions

Randomize

Randomize to naive-treatment HIV-infected patients to receive dual o triple therapy as initial antiretroviral treatment

Intervention Type: DRUG

Other Intervention Names

Triple therapy

Eligibility Criteria

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:

• Complete 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;
• Any intrauterine device with published data showing that the expected failure rate is <1% per year (not all intrauterine devices meet this criterion)
• Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject.
• Approved hormonal contraception.
• Any other method with published data showing that the expected failure rate is <1% per year.
• Signed written informed consent prior to inclusion.

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 to the respective full prescribing information.
• Estimated creatinine clearance <50ml/min.
• History or presence of allergy to the study drugs or their components

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role: lead

Responsible Party

Luis F. Lopez-Cortes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Luis F Lopez-Cortes, MD, PhD

Role: primary

lflopez@us.es

34 - 955013096

References

Saborido-Alconchel A, Serna-Gallego A, Lopez-Cortes LE, Trujillo-Rodriguez M, Praena-Fernandez JM, Dominguez-Macias M, Lozano C, Munoz-Muela E, Espinosa N, Roca-Oporto C, Sotomayor C, Herrero M, Gutierrez-Valencia A, Lopez-Cortes LF. Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV. J Antimicrob Chemother. 2023 Sep 5;78(9):2354-2360. doi: 10.1093/jac/dkad245.

Reference Type: DERIVED

PMID: 37545387 (View on PubMed)

Other Identifiers

FIS-TAR-01-2019

Identifier Type: -

Identifier Source: org_study_id