Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1 - Full Text View

Sponsors and Collaborators:	University of Washington Merck
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00781287

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 IV

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	20
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Raltegravir + 3-drug anti-HIV therapy: Experimental	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
3-drug anti-HIV therapy: Active Comparator	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

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

Contacts

Contact: Janine Maenza, MD	206-667-2300	janine@u.washington.edu
Contact: Claire Stevens, PA-C	206-667-2300	claires@u.washington.edu

Locations

United States, Washington
University of Washington Primary Infection Clinic	Recruiting
Seattle, Washington, United States, 98195
Contact: Janine Maenza, MD 206-667-2300
Sub-Investigator: Janine Maenza, MD

Sponsors and Collaborators

University of Washington

Merck

Investigators

Principal Investigator:

Ann C. Collier, MD

University of Washington

More Information

Additional Information:

University of Washington Primary Infection Clinic web site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Washington ( Ann C. Collier )
Study ID Numbers:	34908
Study First Received:	October 24, 2008
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00781287 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

human immunodeficiency virus
raltegravir
primary HIV infection
HIV-1

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Protease Inhibitors

Virus Diseases
Anti-Retroviral Agents
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009