Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1
Stopped early · Phase 4
Conditions studied: Human Immunodeficiency Virus
In brief
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.
Key facts
- Study ID
- NCT00781287
- Run by
- University of Washington
- People needed
- 10
- Starts
- 2009-02-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2013-08-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University of Washington Primary Infection Clinic — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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