Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.

• Status: Active, not recruiting
• Trial end date: 2021-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase IIa, open clinical trial, pilot, single arm and proof of concept.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Treatments: Dolutegravir; Lamivudine

Criteria

Inclusion Criteria:

1. HIV-1 infected patients.

2. Age> 18 years.

3. Receiving stable antiretroviral treatment for at least 3 months.

4. Current or historical treatment with 3TC or FTC.

5. Willing to change antiretroviral treatment due to intolerance or interest in simplification.

6. Undetectable viral load (<50 cop/mL) for at least 1 year prior to the inclusion. A single viral load >50cop/ml (≤500 copies/ml) is allowed before the three months prior to inclusion in the study, preceded and followed by an undetectable determination.

7. Current level of CD4> 350 cells/μL.

8. Naïve to integrase inhibitors.

9. Patient able to understand and give written informed consent.

10. For those included in group 1 (20 patients): No previous history of virological failure with ART regimen that included 3TC or FTC or previous virological failure had a population genotype without M184V/I or K65R/E/N mutations.

11. For those included in group 2 (20 patients): previous history of virological failure with ART regimen that included 3TC or FTC and historical genotype with M184V/I or K65R/E/N mutations.

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 child-bearing women who do not commit to using an adequate contraceptive method.