Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1 (UW PIC 330)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00781287
Recruitment Status : Terminated (Enrollment too slow.)
First Posted : October 28, 2008
Last Update Posted : August 12, 2013
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ann Collier, University of Washington

October 24, 2008
October 28, 2008
August 12, 2013
February 2009
February 2012   (Final data collection date for primary outcome measure)
Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay [ Time Frame: 96 weeks ]
Same as current
Complete list of historical versions of study NCT00781287 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Human Immunodeficiency Virus
  • Drug: 3-drug anti-HIV therapy
    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)
  • Drug: Raltegravir
    400 mg BID PO
    Other Name: Isentress
  • Experimental: Raltegravir + 3-drug anti-HIV therapy
    • Drug: 3-drug anti-HIV therapy
    • Drug: Raltegravir
  • Active Comparator: 3-drug anti-HIV therapy
    Intervention: Drug: 3-drug anti-HIV therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2013
February 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Ann Collier, University of Washington
University of Washington
Merck Sharp & Dohme Corp.
Principal Investigator: Ann C. Collier, MD University of Washington
University of Washington
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP