CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
Raltegravir (MK-0518) +1 moredrug
Likely dose
Raltegravir (MK-0518) 400 mgfrom 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.

Search/NCT00515827
NCT00515827Phase 2Completed

A Double-Blind, Randomized, Pilot Study to Measure the Effect of Treatment Intensification With a Potent Integrase Inhibitor, Raltegravir (MK-0518), on the Level of Persistent Plasma Viremia Below 50 Copies/ml in Subjects on Protease Inhibitor- or Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Regimens

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 14, 2007·Updated Nov 4, 2021

In Brief

A Phase 2 clinical trial evaluating Raltegravir (MK-0518) and Placebo for HIV Infections. Completed, enrolled 53 participants across 20 sites.

Detailed Summary

Raltegravir (MK-0518) is an HIV-1 integrase inhibitor with potent in vitro activity against HIV-1 strains including those resistant to currently available antiretroviral drugs. The purpose of this study is to assess the effectiveness of raltegravir in further reducing viral load in HIV infected patients that have already achieved viral suppression below the level of detection of standard viral load assays when added to antiretroviral therapy (ART).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 14, 2007
Enrollment StartNov 1, 2007
Primary CompletionSep 1, 2008
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.9 years ago

Interventions

Raltegravir (MK-0518)drug

400 mg tablet taken orally twice daily

Placebodrug

400 mg placebo tablet taken orally twice daily