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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-02

Study Completion Date

2021-07-31

Brief Summary

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

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Detailed Description

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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

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HIV-1-infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm opened with Intervention Type of Drug: Dolutegravir (DTG) and Lamivudina (3TC)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Dolutegravir (DTG)

Intervention Type DRUG

DTG 50 mg tablet will be orally administered once daily with or without food upto 48 weeks

Lamivudine (3TC)

Intervention Type DRUG

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.

Interventions

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Dolutegravir (DTG)

DTG 50 mg tablet will be orally administered once daily with or without food upto 48 weeks

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Tivicay Epivir

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No