Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-02

Study Completion Date

2022-11-30

Brief Summary

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Phase 3b, single arm, single site simplification study of HIV-1 infected patients with virological suppression under the combination of Lamivudine (150 mg BID) plus Raltegravir (400 mg BID) switching to Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD): Roll-over study of the RALAM clinical trial (NCT02284035)

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Detailed Description

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Conditions

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HIV Infections HIV-1-infection HIV Seropositivity

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

Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD)

Group Type EXPERIMENTAL

Raltegravir

Intervention Type DRUG

Raltegravir (1200 mg QD)

Lamivudine

Intervention Type DRUG

Lamivudine (300 mg QD)

Interventions

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Raltegravir

Raltegravir (1200 mg QD)

Intervention Type DRUG

Lamivudine

Lamivudine (300 mg QD)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients in the switch arm who have completed the 24-week follow-up of RALAM (NCT02284035) study and remain virologically suppressed (viral load \<50 copies/mL) on dual therapy with lamivudine plus Raltegravir
* Patients who have signed informed consent to participate in the study.

Exclusion Criteria

* Pregnancy, lactation, or planned pregnancy during the study period
* Any disease or history of disease which, in opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment
* Hepatitis B co-infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No