NCT00781287

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

3 years

First QC Date

October 24, 2008

Last Update Submit

August 8, 2013

Conditions

Human Immunodeficiency Virus

Keywords

human immunodeficiency virusraltegravirprimary HIV infectionHIV-1

Outcome Measures

Primary Outcomes (1)

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

    96 weeks

Secondary Outcomes (5)

  • CD4+ T-cells

    96 weeks

  • Plasma HIV-1 RNA

    96 weeks

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

    From study drug start to 8 weeks after drug discontinuation

  • Plasma HIV-1 RNA

    Baseline to Week 8

  • Tolerability (Discontinuation of raltegravir)

    96 weeks

Study Arms (2)

Raltegravir + 3-drug anti-HIV therapy

EXPERIMENTAL
Drug: 3-drug anti-HIV therapyDrug: Raltegravir

3-drug anti-HIV therapy

ACTIVE COMPARATOR
Drug: 3-drug anti-HIV therapy

Interventions

3-drug anti-HIV therapyDRUG

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)

3-drug anti-HIV therapyRaltegravir + 3-drug anti-HIV therapy
RaltegravirDRUG

400 mg BID PO

Also known as: Isentress
Raltegravir + 3-drug anti-HIV therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Primary Infection Clinic

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ann C. Collier, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 28, 2008

Study Start

February 1, 2009

Primary Completion

February 1, 2012

Study Completion

October 1, 2013

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations

US(1)