Status:
COMPLETED
Tucaresol As Add-On To HAART (Highly Active Antiretroviral Therapy) In Chronic HIV-1 Infected Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
HIV Infection
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
This is a pilot study designed to determine a dose and schedule of Tucaresol that can be administered to HIV-1 infected subjects on HAART (highly active antiretroviral therapy) with viral suppression ...
Eligibility Criteria
Inclusion
- Currently on licensed triple combination therapy, which is defined as two nucleoside analogues (2 NRTI) (excluding Abacavir) and a protease inhibitor (PI) (including boosted PI regimens) or non nucleoside reverse transcriptase inhibitor (NNRTI).
- Must be on the same treatment for at least 3 months prior to study without plans to alter therapy for the next 3 months.
- Plasma HIV-1 RNA (ribonucleic acid)\< 50 copies/mL at screening with a documented history of continuous suppression defined as: the last two readings \< 50 copies/mL for a period of at least 3 months prior to screening.
- Documented CD4+ lymphocyte cell count =350 cells/ml at screening with at least one reading =350 cells/mL in the preceding 3 months and CD4 nadir \>200 cells/ml.
- HBsAg (human hepatitis B Virus surface antigen) and HCV-Ab (human hepatitis C Virus antibody) negative.
Exclusion
- History of hyperimmune or allergic reactions to drug treatment within 3 months prior to study.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00343941
Start Date
November 1 2004
Last Update
October 13 2008
Active Locations (7)
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1
GSK Investigational Site
Bergamo, Lombardy, Italy, 24128
2
GSK Investigational Site
Busto Arsizio (VA), Lombardy, Italy, 21052
3
GSK Investigational Site
Milan, Lombardy, Italy, 20127
4
GSK Investigational Site
Milan, Lombardy, Italy, 20157