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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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)
400 mg BID PO
University of Washington Primary Infection Clinic
Seattle, Washington, United States
Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay
Time frame: 96 weeks
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
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