Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine

Phase 3

Completed

• Conditions: AIDS
• Interventions: Drug: Raltegravir/3TC; 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

• Registration Number: NCT02284035
• Lead Sponsor: Juan A. Arnaiz

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-05
• Study Start: 2015-09-27
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Results First Submitted: 2017-08-10
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Results First Posted: 2025-07-20
• Last Update Posted: 2025-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 standard combination therapy	ATV/r plus ABC/3TC	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
Group 2 standard combination therapy	DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC	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
Group 2 standard combination therapy	RAL plus ABC/3TC	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
Group 2 standard combination therapy	Other ART regimens	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
Group 1 Raltegravir / 3TC (MK0518B	Raltegravir/3TC	Raltegravir / 3TC (MK0518B ) (50 patients)
Group 2 standard combination therapy	EFV/TDF/FTC	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
Group 2 standard combination therapy	ATV/r + TDF/FTC or DRV/r + TDF/FTC	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
Group 2 standard combination therapy	DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC	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
Group 2 standard combination therapy	EFV plus ABC/3TC or RPV/TDF/FTC	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

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Free of Therapeutic Failure	24 weeks	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

Secondary Outcome Measures

Name	Time	Method
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	Composite measure
Changes in Body Fat Composition	24 weeks	Composite measure
Changes in Plasma 25-OH Vitamin D Levels	24 weeks
Changes in Estimated Glomerular Filtration Rate (CKD-EPI)	24 weeks	Composite measure
Changes in CD38	24 weeks
Changes in IL-6	24 weeks
Changes in Sleep Quality (Pittsburgh Sleep Quality Index)	24 weeks	The Pittsburgh Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven áreas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.; The posible range of the scale is from 0 to 21 points. The greater the score the poorest is the sleep quality.
Changes in Adherence in Both Treatment Arms (Morisky-Green Test)	24 weeks	Patients were asked to complete the Morisky-Green questionnaire: Some people forget to take their medication as prescribed. How often does it happen to you? (Always/often/sometimes/rarely/never) Some people forget some taking of the medication or change the prescribed schedule / take to adapt it to their own needs. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel better. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel worse. How often do you do it? (Always/often/sometimes/rarely/never); Only if patients answered never to each four questions, they were considered adherent; if not, non adherent.
Changes in Total Cholesterol	24 weeks
Changes in HDL Cholesterol	24 weeks
Changes in LDL Cholesterol	24 weeks
Changes in Triglycerides	24 weeks
Changes in Bone Mineral Density	24 weeks	DEXA
Changes in Urine Beta-2-microglobulin/Creatinine Ratio	24 weeks
Changes in HLA-DR	24 weeks
Changes in High Sensitivity C-reactive Protein	24 weeks
Changes in Mononuclear Activation SD-14	24 weeks
Changes in Mononuclear Activation SD-163	24 weeks

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain