Trial Outcomes & Findings for MK-0518 Intensification And HDAC Inhibition In Depletion Of Resting CD4+ T Cell HIV Infection (NCT NCT00614458)

NCT ID: NCT00614458

Last Updated: 2011-10-25

Results Overview

A change in infected cells from prior to the initiation of VPA and MK0518 to after 20 weeks of treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 20 weeks
• Results posted on: 2011-10-25

Participant Flow

Participant milestones

Measure	Effect on Latent HIV of Adding Raltegravir and VPA to ART Single arm pilot study that measured the effect of adding Raltegravir and Valproic acid (VPA) and current antiretroviral therapy (ART) on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MK-0518 Intensification And HDAC Inhibition In Depletion Of Resting CD4+ T Cell HIV Infection

Baseline characteristics by cohort

Measure	Effect on Latent HIV of Adding Raltegravir and/or VPA to ART n=6 Participants Single arm pilot study that measured the effect of adding Raltegravir and/or VPA and current ART on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	36 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 20 weeks

Population: All participants analyzed per protocol

A change in infected cells from prior to the initiation of VPA and MK0518 to after 20 weeks of treatment.

Outcome measures

Measure	Effect on Latent HIV of Adding Raltegravir and VPA to ART n=6 Participants
A Change in the Number of HIV Infected Cells.	0.390 infected cells /million cells Interval 0.03 to 10.0

Adverse Events

Effect on Latent HIV of Adding Raltegravir and/or VPA to ART

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor of Medicine, Director Translational Research IGHID

UNC Chapel Hill

Phone: 919 966 6388

Email: dmargo@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place