Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine

AIDS Clinical Trial

— RALAM  

Official title:

Pilot 24week Clinical Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Raltegravir/Lamivudine Combination, Replacing Standard Combination Therapy in HIV-infected Pts With Prolonged Virological Suppression.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02284035
• Other study ID #: RALAM
• Secondary ID: 2014-003142-27
• Status: Recruiting
• Phase: Phase 3
• First received: October 28, 2014
• Last updated: June 29, 2016
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Hospital Clinic of Barcelona
• Contact: Esteban Martinez, MD PhD
• Phone: +34932275400
• Email: estebanm[@]clinic.ub.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AIDS

Intervention

Drug:
• Raltegravir/3TC
MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
• EFV/TDF/FTC
standard combination therapy
• ATV/r + TDF/FTC or DRV/r + TDF/FTC

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

• EFV plus ABC/3TC or RPV/TDF/FTC

• ATV/r plus ABC/3TC

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

• RAL plus ABC/3TC

• Other ART regimens

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy in virological suppression assessed with standard plasma HIV-1 RNA detection	Efficacy in virological suppression assessed with standard plasma HIV-1 RNA detection	24 weeks
Secondary	Efficacy in virological suppression assessed with ultrasensitive HIV-1 RNA detection (limit of detection 1 copy/mL)	efficacy in virological suppression assessed with ultrasensitive HIV-1 RNA detection (limit of detection 1 copy/mL)	24 weeks
Secondary	changes in peripheral mononuclear blood cells HIV-1 reservoir		24 weeks
Secondary	changes in insulin resistance (HOMA-IR)	Composite measure	24 weeks
Secondary	changes in body fat composition	Composite measure	24 weeks
Secondary	changes in plasma 25-OH vitamin D levels		24 weeks
Secondary	changes in estimated glomerular filtration rate (CKD-EPI)	Composite measure	24 weeks
Secondary	changes in CD38		24 weeks
Secondary	changes in IL-6		24 weeks
Secondary	changes in sleep quality (Pittsburgh Sleep Quality Index)		24 weeks
Secondary	changes in adherence in both treatment arms (Morisky-Green Test)overall tolerability		24 weeks
Secondary	Changes in total cholesterol		24 weeks
Secondary	Changes in HDL cholesterol		24 weeks
Secondary	Changes in LDL cholesterol		24 weeks
Secondary	Changes in triglycerides		24 weeks
Secondary	Changes in bone mineral density	DEXA	24 weeks
Secondary	Changes in urine beta-2-microglobulin		24 weeks
Secondary	changes in HLA-DR		24 weeks
Secondary	Changes in high sensitivity C-reactive protein		24 weeks
Secondary	Changes in mononuclear activation SD-14		24 weeks
Secondary	Changes in mononuclear activation SD-163		24 weeks