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R5 Integrase Study in HIV-1 Naive Patients

NCT01204905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-11-14

Study results available
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Summary

This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads \> 5,000. The subjects will be followed for 48 weeks. The combination of these two agents has the potential to be a potent regimen with minimal metabolic complications. However, they have not been studied in combination previously.

This pilot study proposes to evaluate this combination in antiretroviral naïve patients to document the safety and efficacy of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications.

Conditions

  • HIV Infections

Interventions

DRUG

Raltegravir and Maraviroc in combination

Raltegravir 400 mg tablet twice a day, \~12 hours (10 to 14 hours) apart Maraviroc 300 mg tablet twice a day, \~12 hours (10 to 14 hours) apart

Sponsors & Collaborators

Principal Investigators

  • Robert R. Redfield, MD · University of Maryland, Institute of Human Virology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-05-16
Completion
2014-05-16

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01204905 on ClinicalTrials.gov