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

NCT ID: NCT00781287

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Human Immunodeficiency Virus

Keywords

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human immunodeficiency virus raltegravir primary HIV infection HIV-1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Raltegravir + 3-drug anti-HIV therapy

Group Type EXPERIMENTAL

3-drug anti-HIV therapy

Intervention Type DRUG

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)

Raltegravir

Intervention Type DRUG

400 mg BID PO

3-drug anti-HIV therapy

Group Type ACTIVE_COMPARATOR

3-drug anti-HIV therapy

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Raltegravir

400 mg BID PO

Intervention Type DRUG

Other Intervention Names

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Isentress

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Ann Collier

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann C. Collier, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington Primary Infection Clinic

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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34908-D

Identifier Type: -

Identifier Source: org_study_id