Antiretroviral treatment guiaded by proviral genotype

Phase 1

• Conditions: Human Immunodeficiency Virus; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-000151-10-ES
• Lead Sponsor: Fundación para la Investigación Biomédica del Hospital Universitario La Paz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-12
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patient infected with HIV-1.
2. Age> 18 years.
3. Receiving stable antiretroviral treatment for at least 3 months.
4. Current or historical treatment with 3TC or FTC.
5. Desire to change antiretroviral treatment due to intolerance or interest in simplification.
6. Undetectable viral load (<50 copies/mL) for at least 1 year. A blip (=500 copies/mL) is allowed within three months prior to inclusion in the study, preceded and followed by undetectable determination.
7. Current CD4 level> 350 cells/µL.
8. Naïve to integrase inhibitors.
9. Able to understand and give written informed consent.
10. For those included in group 1 (20 patients): no history of virological failure with an ART regimen that included 3TC or FTC or at the time of failure had a population genotype without M184V/I or K65R/E/N.
11. For those included in group 2 (20 patients): history of virological failure with TAR guideline including 3TC or FTC and historical genotype with mutations M184V/I or K65R /E/N.
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Detection of any of the following mutations in proviral DNA in peripheral blood by conventional sequencing: M184V/I or K65R/E/N.
2. Pregnant, lactating or fertile women who do not commit to using an adequate contraceptive method.

Study & Design

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