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

This study has been terminated.
(Enrollment too slow.)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ann Collier, University of Washington
ClinicalTrials.gov Identifier:
NCT00781287
First received: October 24, 2008
Last updated: August 8, 2013
Last verified: August 2013

October 24, 2008
August 8, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00781287 on ClinicalTrials.gov Archive Site
  • CD4+ T-cells [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Plasma HIV-1 RNA [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Plasma HIV-1 RNA [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Tolerability (Discontinuation of raltegravir) [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    Interventions:
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00781287
34908-D
No
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