Phase IIa, open clinical trial, pilot, single arm and proof of concept.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
DTG 50 mg tablet will be orally administered once daily with or without food upto 48 weeks
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.
Hospital 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks
\- Efficacy: Proportion of patients with undetectable viral load (\<50 copies / mL) at 48 weeks of follow-up, according to the FDA snapshot algorithm in the population "by intention to treat-exposed". The intention-to-treat population includes all patients who have received at least one dose of DTG and 3TC.
Time frame: Week 48
Proportion of patients with virological failure at 24 weeks
Proportion of patients with viral load \<50 copies/ml at week 24, according to the FDA snapshot algorithm in the population "by intention to treat-exposed".
Time frame: Week 24
Proportion of patients with virological failure at 48 weeks
Proportion of patients with virological failure at week 48 according to the FDA snapshot algorithm.
Time frame: Week 48
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of adverse events and discontinuation of treatment due to toxicity or intolerance.
Time frame: Since baseline visits to week 48
Evaluation of the appearance of genotypic resistance mutations (1)
Incidence of genotypic resistance mutations in patients with virological failure at week 48. Description and frequency of genotypic resistance mutations.
Time frame: Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.