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
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus
Drug: 3-drug anti-HIV therapy
Drug: Raltegravir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: February 2009
Estimated Study Completion Date: October 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raltegravir + 3-drug anti-HIV therapy 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
Active Comparator: 3-drug anti-HIV therapy 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)

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 values. The 3-drug HAART will be chosen and provided by the subject.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781287

Locations
United States, Washington
University of Washington Primary Infection Clinic
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Ann C. Collier, MD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Ann Collier, Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT00781287     History of Changes
Other Study ID Numbers: 34908-D
Study First Received: October 24, 2008
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
human immunodeficiency virus
raltegravir
primary HIV infection
HIV-1

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014