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Seattle, Washington 98195


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 summary:

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)



Primary Contact:

Principal Investigator
Ann C. Collier, MD
University of Washington

Backup Contact:


Location Contact:

Seattle, Washington 98195
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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