Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03539224|
Recruitment Status : Active, not recruiting
First Posted : May 29, 2018
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection||Drug: Dolutegravir (DTG) Drug: Lamivudine (3TC)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm opened with Intervention Type of Drug: Dolutegravir (DTG) and Lamivudina (3TC)|
|Masking:||None (Open Label)|
|Official Title:||Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.|
|Actual Study Start Date :||November 2, 2017|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: Dolutegravir (DTG) + Lamivudine (3TC)
Eligible subjects will receive one 50 mg tablet of DTG plus 300 mg 3TC tablet orally once daily upto 48 weeks
Drug: Dolutegravir (DTG)
DTG 50 mg tablet will be orally administered once daily with or without food upto 48 weeks
Other Name: Tivicay
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.
Other Name: Epivir
- Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks [ Time Frame: Week 48 ]- 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.
- Proportion of patients with virological failure at 24 weeks [ Time Frame: Week 24 ]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".
- Proportion of patients with virological failure at 48 weeks [ Time Frame: Week 48 ]Proportion of patients with virological failure at week 48 according to the FDA snapshot algorithm.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Since baseline visits to week 48 ]Incidence of adverse events and discontinuation of treatment due to toxicity or intolerance.
- Evaluation of the appearance of genotypic resistance mutations (1) [ Time Frame: Week 48 ]Incidence of genotypic resistance mutations in patients with virological failure at week 48. Description and frequency of genotypic resistance mutations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539224
|Hospital 12 de Octubre|
|Madrid, Spain, 28041|
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|