Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen

HIV Clinical Trial

Official title:

A Pilot Study to Assess the Downregulation of HIV-1 Associated Chronic Inflammation in Patients With Limited Immunologic Responses When Raltegravir is Added to a Virologically Suppressed HAART Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738569
• Other study ID #: Merck HIV
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: February 2011

Study information

• Verified date: January 2021
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least 18 years of age

2. HIV-positive by Western blot or viral load

3. Viral load < 400 copies/ml

4. 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

Exclusion Criteria:

1. 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

2. Viral load > 400 copies/ml

3. Allergy or resistance to raltegravir

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Raltegravir
Raltegravir 400 mg PO BID for 12 months

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative changes in activated CD4+/CD8+ T-lymphocytes, pro-inflammatory cytokines and the central memory cell pool		12 months
Secondary	Measure the change in circulating CD4+ and CD8+ T-lymphocytes		12 months
Secondary	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