NCT02284035

Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Juan A. Arnaiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DRUG	EFV/TDF/FTC	standard combination therapy
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

Timeline

• Start date: 2015-09-27
• Primary completion: 2017-02-28
• Completion: 2017-02-28
• First posted: 2014-11-05
• Last updated: 2025-07-20
• Results posted: 2025-07-20

Locations

1 site across 1 country: Spain