Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1

Overview

This is an investigator-initiated, two-year, randomized, controlled, single-center, open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to 3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. The study will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg BID orally) to inhibit the integration step of the HIV-1 life cycle in conjunction with HAART in subjects with recently acquired HIV-1 infection will decrease the number of HIV-1 infected CD4+ T-cells to a greater extent than a 3-drug HAART regimen.

Full Title of Study: “Impact of Raltegravir (Isentress/MK-0518) – Containing Regimens on HIV-1 Infected CD4+ T-Cells During Acute and Early HIV-1 Infection: A Randomized, Controlled Study Comparing Standard Antiretroviral Therapy to Standard Therapy Plus Raltegravir”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2012

Detailed Description

The study will be conducted at the UW Primary Infection Clinic and the UW AIDS Clinical Trials Unit. Secondary objectives will characterize safety, tolerability, plasma HIV-1 RNA and CD4+ T-cell values. The 3-drug HAART will be chosen and provided by the subject.

Interventions

  • Drug: 3-drug anti-HIV therapy
    • 3 FDA-approved drugs, including two nucleos(t)ide reverse transcriptase inhibitors and either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor (Low dose ritonavir can be used to enhance the protease inhibitor and is not considered one of the 3 anti-HIV drugs)
  • Drug: Raltegravir
    • 400 mg BID PO

Arms, Groups and Cohorts

  • Experimental: Raltegravir + 3-drug anti-HIV therapy
  • Active Comparator: 3-drug anti-HIV therapy

Clinical Trial Outcome Measures

Primary Measures

  • Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay
    • Time Frame: 96 weeks

Secondary Measures

  • CD4+ T-cells
    • Time Frame: 96 weeks
  • Plasma HIV-1 RNA
    • Time Frame: 96 weeks
  • Grade 3 and 4 signs and symptoms or laboratory toxicities at least one grade higher than baseline
    • Time Frame: From study drug start to 8 weeks after drug discontinuation
  • Plasma HIV-1 RNA
    • Time Frame: Baseline to Week 8
  • Tolerability (Discontinuation of raltegravir)
    • Time Frame: 96 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Acute or Early HIV-1 infection – HIV-1 RNA > or equal to 500 copies/mL – Acceptable safety lab results (specified in protocol) – Negative pregnancy test for females – Willingness to use contraception (for females of reproductive potential Exclusion Criteria:

  • Prior receipt of investigational HIV-1 vaccine – Use of immunomodulators other than systemic steroids within 30 days before entry – Serious medical or psychiatric illness that would interfere with study participation – Active drug or alcohol use that would interfere with study participation – Allergy/hypersensitivity to raltegravir – Pre- or Post-exposure prophylaxis for the exposure that led to HIV-1 acquisition – Pregnancy or breastfeeding – History of malignancy (other than localized squamous cell or basal cell cancer of the skin)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ann Collier, Professor of Medicine – University of Washington
  • Overall Official(s)
    • Ann C. Collier, MD, Principal Investigator, University of Washington

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.