Brief Summary

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Official Title: "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"

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.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: February 2012

Detailed Clinical Trial 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 Used in this Clinical Trial

• 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 in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

• Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay
  • Time Frame: 96 weeks
    Safety Issue?: No

Secondary Measures

• CD4+ T-cells
  • Time Frame: 96 weeks
    Safety Issue?: Yes
• Plasma HIV-1 RNA
  • Time Frame: 96 weeks
    Safety Issue?: No
• 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
    Safety Issue?: Yes
• Plasma HIV-1 RNA
  • Time Frame: Baseline to Week 8
    Safety Issue?: No
• Tolerability (Discontinuation of raltegravir)
  • Time Frame: 96 weeks
    Safety Issue?: Yes

Criteria for Participation 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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • University of Washington
• Collaborator
  • Merck
• 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