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Addition of Raltegravir to Established Antiretroviral Suppressive Therapy

NCT01245101 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-12-23

Study results available
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Summary

This study will examine whether intensification with raltegravir of a suppressive antiretroviral regimen in HIV infected patients with poor immune restoration has a beneficial effect on cryptic viral replication and the immune system. Specifically, the investigators will examine the effect that raltegravir intensification of ART has on episomal cDNA frequencies, immune activation, CD4+ cell counts and apoptosis, and markers of microbial translocation.

Conditions

Interventions

DRUG

Raltegravir

Raltegravir 400 mg twice daily in addition to subject's antiretroviral therapy.

DRUG

Raltegravir

Raltegravir 400 mg twice daily in addition to subject's antiretroviral therapy.

Sponsors & Collaborators

Principal Investigators

  • Rafael E Campo, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-10-31
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01245101 on ClinicalTrials.gov