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

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.

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.

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)