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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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 or disease	Intervention/treatment	Phase
Human Immunodeficiency Virus	Drug: 3-drug anti-HIV therapy; Drug: Raltegravir	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	10 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	February 2009
Actual Primary Completion Date :	February 2012
Estimated Study Completion Date :	October 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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)

Outcome Measures

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Primary Outcome Measures :

1. Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay [ Time Frame: 96 weeks ]

Secondary Outcome Measures :

1. CD4+ T-cells [ Time Frame: 96 weeks ]
2. Plasma HIV-1 RNA [ Time Frame: 96 weeks ]
3. 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 ]
4. Plasma HIV-1 RNA [ Time Frame: Baseline to Week 8 ]
5. Tolerability (Discontinuation of raltegravir) [ Time Frame: 96 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

University of Washington Primary Infection Clinic web site 

Responsible Party:	Ann Collier, Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier:	NCT00781287 History of Changes
Other Study ID Numbers:	34908-D
First Posted:	October 28, 2008
Last Update Posted:	August 12, 2013
Last Verified:	August 2013

Keywords provided by Ann Collier, 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; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases	Slow Virus Diseases; Raltegravir Potassium; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action