At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 75 enrolled
Drug / intervention
Raltegravir/3TC +8 moredrug
Likely dose
Raltegravir/3TC 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Raltegravir/3TC, EFV/TDF/FTC, and 7 other interventions for AIDS. Completed, enrolled 75 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAIDS
CountriesSpain
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartSep 2015
Primary CompletionFeb 2017
TodayJul 2026
First PostedNov 5, 2014
Enrollment StartSep 27, 2015
Primary CompletionFeb 28, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.7 years ago
Interventions
Raltegravir/3TCdrug
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/FTCdrug
standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTCdrug
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTCdrug
EFV plus ABC/3TC or RPV/TDF/FTCdrug
ATV/r plus ABC/3TCdrug
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTCdrug
RAL plus ABC/3TCdrug
Other ART regimensdrug