Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine (RALAM)

Juan A. Arnaiz

Status and phase: Completed; Phase 3

Conditions: AIDS

Treatments: Drug: ATV/r + TDF/FTC or DRV/r + TDF/FTC; Drug: ATV/r plus ABC/3TC; Drug: RAL plus ABC/3TC; Drug: EFV/TDF/FTC; Drug: Other ART regimens; Drug: EFV plus ABC/3TC or RPV/TDF/FTC; Drug: DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC; Drug: Raltegravir/3TC; Drug: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC

Study type: Interventional

Funder types: Other

Identifiers

NCT02284035

2014-003142-27 (EudraCT Number)

RALAM

Details and patient eligibility

About

A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected patients with prolonged virological suppression

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Patients seropositive for HIV-1 using standard diagnostic criteria.
3. Patients virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
4. Patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.
5. Patients who are clinically stable in the opinion of the investigator at study entry (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization).
6. Patients who have signed informed consent to participate in the study.

Exclusion criteria

1. Pregnancy, lactation, or planned pregnancy during the study period.
2. Previous failure to an integrase inhibitor-containing regimen.
3. Previous failure to a 3TC or FTC-containing regimen.
4. Resistance mutations to 3TC or integrase inhibitor if any resistance test had been previously performed.
5. 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.
6. Chronic hepatitis B.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Group 1 Raltegravir / 3TC (MK0518B

Experimental group

Description:

Raltegravir / 3TC (MK0518B ) (50 patients)

Treatment:

Drug: Raltegravir/3TC

Group 2 standard combination therapy

Active Comparator group

Description:

NNRTI-Based Regimen: • EFV/TDF/FTC PI-Based Regimens: ATV/r + TDF/FTC or DRV/r + TDF/FTC INSTI-Based Regimens: DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC NNRTI-Based Regimens: EFV plus ABC/3TC or RPV/TDF/FTC PI-Based Regimen: ATV/r plus ABC/3TC PI-Based Regimens: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC INSTI-Based Regimen: RAL plus ABC/3TC And other ART regimens

Treatment:

Drug: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC

Drug: DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC

Drug: EFV plus ABC/3TC or RPV/TDF/FTC

Drug: Other ART regimens

Drug: EFV/TDF/FTC

Drug: RAL plus ABC/3TC

Drug: ATV/r plus ABC/3TC

Drug: ATV/r + TDF/FTC or DRV/r + TDF/FTC