NCT03539224

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Proof of concept trial evaluating safety and efficacy of treatment with Dolutegravir (DTG) + lamivudine (3TC) once daily in suppressed participants with history of previous treatment with 3TC or emtricitabine (FTC). Half of the participants will have history of failure with 3TC or FTC and M184V/I or K65R/E/N mutations in previous plasma genotypes, although to be eligible these mutations cannot be detectable at study entry in proviral DNA.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Dolutegravir (DTG)	DTG 50 mg tablet will be orally administered once daily with or without food upto 48 weeks
DRUG	Lamivudine (3TC)	Lamivudine will be dispensed as 300 mg white, diamond shaped, scored, film coated tablets. It will be orally administered once daily with or without food upto 48 weeks.

Timeline

• Start date: 2017-11-02
• Primary completion: 2021-05-31
• Completion: 2021-07-31
• First posted: 2018-05-29
• Last updated: 2020-07-07

Locations

2 sites across 1 country: Spain