Status:
TERMINATED
Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 raltegrav...
Detailed Description
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 value...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00781287
Start Date
February 1 2009
End Date
October 1 2013
Last Update
August 12 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Washington Primary Infection Clinic
Seattle, Washington, United States, 98195