Triple vs. Double Therapy in naïves HIV-Infected Patients

NCT04295460 | Unknown Phase 4 DMC

• 1 other identifier: FIS-TAR-01-2019
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• proviral HIV-DNA

  Mean changes in proviral HIV-DNA in PBMCs after 48 and 96 weeks of treatment

  48 and 96 weeks

Secondary Outcomes (6)

• Immune Recovery

  48 and 96 weeks

• Immune Activation

  48 and 96 weeks

• Monocytes Activation

  48 and 96 weeks

• Immunosenescense

  48 and 96 weeks

• Inflammation

  48 and 96 weeks

Other Outcomes (2)

• Semen

  24 weeks

• GALT

  48 weeks

Study Arms (2)

Dual Therapy

EXPERIMENTAL

Dolutegravir plus lamivudine

Drug: Randomize

Triple Therapy

ACTIVE COMPARATOR

Dolutegravir plus TAF/FTC

Drug: Randomize

Interventions

Randomize DRUG

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

Also known as: Triple therapy

Dual Therapy; Triple Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Acute HIV infection
• T lymphocyte CD4+ count in peripheral blood ≤ 200/µl
• Active opportunistic infection.
• 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

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead

Study Sites (1)

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 37545387 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: March 10, 2020
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2023
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

ES (1)