Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-03

Study Completion Date

2020-06-25

Brief Summary

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Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.

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Detailed Description

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Conditions

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HIV Seropositivity HIV Infections HIV-1-infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Raltegravir + Lamivudine

Group Type EXPERIMENTAL

Raltegravir

Intervention Type DRUG

Raltegravir (1200 mg once a day)

Lamivudine

Intervention Type DRUG

Lamivudine (300 mg once a day)

Interventions

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Raltegravir

Raltegravir (1200 mg once a day)

Intervention Type DRUG

Lamivudine

Lamivudine (300 mg once a day)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.
* Patients seropositive for HIV-1 using standard diagnostic criteria.
* Patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen
* Patients virologically suppressed during at least 12 months prior to inclusion (viral load \<50 copies/mL).
* Patients who have signed informed consent to participate in the study.

Exclusion Criteria

* Pregnancy, lactation, or planned pregnancy during the study period.
* Previous failure to an integrase inhibitor-containing regimen.
* Previous failure to a Lamivudine or Emtricitabine-containing regimen.
* Resistance mutations to Lamivudine or integrase inhibitor if any resistance test had been previously performed.
* Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
* Chronic hepatitis B.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No