Expired Study
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Seattle, Washington 98195


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.


Study summary:

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.


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)


Study is Available At:


Original ID:

34908-D


NCT ID:

NCT00781287


Secondary ID:


Study Acronym:

UW PIC 330


Brief Title:

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


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


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Washington


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Enrollment too slow.


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ann C. Collier, MD
Principal Investigator
University of Washington

Study Dates

Start Date:February 2009
Completion Date:October 2013
Completion Type:Anticipated
Primary Completion Date:February 2012
Primary Completion Type:Actual
Verification Date:August 2013
Last Changed Date:August 8, 2013
First Received Date:October 24, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Tolerability (Discontinuation of raltegravir)
Time Frame:96 weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Plasma HIV-1 RNA
Time Frame:Baseline to Week 8
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Plasma HIV-1 RNA
Time Frame:96 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:CD4+ T-cells
Time Frame:96 weeks
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay
Time Frame:96 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:3-drug anti-HIV therapy
Description: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)
Arm Name:Raltegravir + 3-drug anti-HIV therapy
Intervention Type:Drug
Name:Raltegravir
Description:400 mg BID PO
Arm Name:Raltegravir + 3-drug anti-HIV therapy
Other Name:Isentress

Study Arms

Study Arm Type:Active Comparator
Arm Name:3-drug anti-HIV therapy
Study Arm Type:Experimental
Arm Name:Raltegravir + 3-drug anti-HIV therapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Washington
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Merck

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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