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Triple vs. Double Therapy in naïves HIV-Infected Patients | Clinical Trials | Clareo Health

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Triple vs. Double Therapy in naïves HIV-Infected Patients

Effectiveness of a Dual Therapy (Dolutegravir + Lamivudine) on Reduction of the Viral Reservoir, Immune Recovery and Immune Activation Compared With a Triple Therapy (Dolutegravir + Tenofovir Alafenamide/Emtricitabine) in Treatment-naïve HIV-Infected Patients

NCT04295460•Hospitales Universitarios Virgen del Rocío

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+3 more criteria

Locations (1)

Hospital Universitario Virgen del Rocio

Seville, Spain

Key Dates

Start Date

March 10, 2020

Primary Completion Date

January 1, 2022

Completion Date

March 1, 2023

Last Updated

August 18, 2020

Enrollment

ESTIMATED participants

Conditions

HIV Infection

Interventions

Randomize

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 18, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Triple vs. Double Therapy in naïves HIV-Infected Patients

Inclusion Criteria

Exclusion Criteria

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