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

• Status: Terminated
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Raltegravir Potassium

Criteria

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)