NCT00738569

Brief Summary

The purpose of this study is to determine whether or not adding Raltegravir to a fully suppressive antiretroviral regimen will assist in reducing HIV-1 associated chronic inflammation and increase the t-lymphocyte memory cell pool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

2.6 years

First QC Date

August 19, 2008

Last Update Submit

January 15, 2021

Conditions

HIV

Keywords

Chronic inflammationmemory cellsactivated t-lymphocytes

Outcome Measures

Primary Outcomes (1)

  • Quantitative changes in activated CD4+/CD8+ T-lymphocytes, pro-inflammatory cytokines and the central memory cell pool

    12 months

Secondary Outcomes (2)

  • Measure the change in circulating CD4+ and CD8+ T-lymphocytes

    12 months

  • Determine whether the circulating CD8+ T-lymphocyte count or the CD4+/CD8+ ratio can serve as a surrogate marker for suppression of chronic inflammation

    12 months

Study Arms (1)

Raltegravir

EXPERIMENTAL
Drug: Raltegravir

Interventions

RaltegravirDRUG

Raltegravir 400 mg PO BID for 12 months

Also known as: Brand name is Isentress
Raltegravir

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age
  • HIV-positive by Western blot or viral load
  • Viral load \< 400 copies/ml
  • CD4+ T-lymphocyte count less than 350 cells/mm3 or change in CD4+ T-lymphocyte count \< 100 cells/mm3 for at least one year on stable HAART with viral load \< 400 copies/ml for the same period of time

You may not qualify if:

  • CD4+ T-lymphocyte count greater than or equal to 350 cells/mm3 or rise in CD4+ T-lymphocyte count greater than or equal to 100 cells/mm3 within one year of study entry
  • Viral load \> 400 copies/ml
  • Allergy or resistance to raltegravir

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

MeSH Terms

Interventions

Raltegravir Potassium

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kenneth A Lichtenstein, MD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

July 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

US(1)