Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine

NCT02284035 | Completed Phase 3 Results

• 2 other identifiers: RALAM2014-003142-27
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

AIDS

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Free of Therapeutic Failure

  Proportion of patients free of therapeutic failure at week 24. Therapeutic failure includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death

  24 weeks

Secondary Outcomes (20)

• Efficacy in Virological Suppression Assessed With Ultrasensitive HIV-1 RNA Detection (Limit of Detection 1 Copy/mL)

  24 weeks

• Changes in Peripheral Mononuclear Blood Cells HIV-1 Reservoir

  24 weeks

• Changes in Insulin Resistance (HOMA-IR)

  24 weeks

• Changes in Body Fat Composition

  24 weeks

• Changes in Plasma 25-OH Vitamin D Levels

  24 weeks

Study Arms (2)

Group 1 Raltegravir / 3TC (MK0518B

EXPERIMENTAL

Raltegravir / 3TC (MK0518B ) (50 patients)

Drug: Raltegravir/3TC

Group 2 standard combination therapy

ACTIVE COMPARATOR

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

Drug: EFV/TDF/FTC; Drug: ATV/r + TDF/FTC or DRV/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: ATV/r plus ABC/3TC; Drug: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC; Drug: RAL plus ABC/3TC; Drug: Other ART regimens

Interventions

Raltegravir/3TC DRUG

MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.

Group 1 Raltegravir / 3TC (MK0518B

EFV/TDF/FTC DRUG

standard combination therapy

Also known as: NNRTI-Based Regimen

Group 2 standard combination therapy

ATV/r + TDF/FTC or DRV/r + TDF/FTC DRUG

Also known as: PI-Based Regimens

Group 2 standard combination therapy

DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC DRUG

Also known as: INSTI-Based Regimens

Group 2 standard combination therapy

EFV plus ABC/3TC or RPV/TDF/FTC DRUG

Also known as: NNRTI-Based Regimens

Group 2 standard combination therapy

ATV/r plus ABC/3TC DRUG

Also known as: PI-Based Regimen

Group 2 standard combination therapy

DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC DRUG

Also known as: PI-Based Regimens

Group 2 standard combination therapy

RAL plus ABC/3TC DRUG

Also known as: INSTI-Based Regimen

Group 2 standard combination therapy

Other ART regimens DRUG

Group 2 standard combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.
• 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).
• Patients who have signed informed consent to participate in the study.

You may not qualify if:

• Pregnancy, lactation, or planned pregnancy during the study period.
• Previous failure to an integrase inhibitor-containing regimen.
• Previous failure to a 3TC or FTC-containing regimen.
• Resistance mutations to 3TC 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.

Sponsors & Collaborators

• Juan A. Arnaiz: lead

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

efavirenz

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Esteban Martínez
• Organization: Hospital Clinic of Barcelona

ESTEBANM@clinic.cat

+34 93 227 54 00

Study Officials

• Esteban Martinez, MD PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Clinical Trials Unit

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 5, 2014
• Study Start: September 27, 2015
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: July 20, 2025
• Results First Posted: July 20, 2025

Record last verified: 2025-07

Locations

ES (1)