Back to results

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

Primary Purpose

Human Immunodeficiency Virus

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

3-drug anti-HIV therapy

Raltegravir

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring human immunodeficiency virus, raltegravir, primary HIV infection, HIV-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of Washington Primary Infection Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Raltegravir + 3-drug anti-HIV therapy

3-drug anti-HIV therapy

Arm Description

Outcomes

Primary Outcome Measures

Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay

Secondary Outcome Measures

CD4+ T-cells

Plasma HIV-1 RNA

Grade 3 and 4 signs and symptoms or laboratory toxicities at least one grade higher than baseline

Plasma HIV-1 RNA

Tolerability (Discontinuation of raltegravir)

Full Information

NCT ID

NCT00781287

First Posted

October 24, 2008

Last Updated

August 8, 2013

Sponsor

University of Washington

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00781287

Brief Title

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

Acronym

UW PIC 330

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 Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Terminated

Why Stopped

Enrollment too slow.

Study Start Date

February 2009 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus

Keywords

human immunodeficiency virus, raltegravir, primary HIV infection, HIV-1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Raltegravir + 3-drug anti-HIV therapy

Arm Type

Experimental

Arm Title

3-drug anti-HIV therapy

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

3-drug anti-HIV therapy

Intervention 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)

Intervention Type

Drug

Intervention Name(s)

Raltegravir

Other Intervention Name(s)

Isentress

Intervention Description

400 mg BID PO

Primary Outcome Measure Information:

Title

Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay

Time Frame

96 weeks

Secondary Outcome Measure Information:

Title

CD4+ T-cells

Time Frame

96 weeks

Title

Plasma HIV-1 RNA

Time Frame

96 weeks

Title

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

Title

Plasma HIV-1 RNA

Time Frame

Baseline to Week 8

Title

Tolerability (Discontinuation of raltegravir)

Time Frame

96 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ann C. Collier, MD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington Primary Infection Clinic

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs