Status:
TERMINATED
Safety Study of TXA127 to Elevate CD4+ T-Lymphocyte Counts in HIV-Infected Patients on Stable HAART Therapy
Lead Sponsor:
US Biotest, Inc.
Collaborating Sponsors:
Tarix Pharmaceuticals
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test the safety of an investigational medication, TXA127, and its ability to increase T-lymphocyte counts, specifically CD4+ T-lymphocytes, in persons infected with hum...
Detailed Description
This is a Phase I, single institution, open-label, within-dosing-cohort-schedule randomized, dose escalation study of TXA127 in HIV-infected subjects with CD4+ T-lymphocyte counts less than 250 per mm...
Eligibility Criteria
Inclusion
- HIV-infected males or non-pregnant, non-breast-feeding females who are \>= 18 years of age;
- CD4+ T-lymphocyte count less than 250 per mm3;
- Successful response to HAART (defined as an HIV RNA viral load of \<50 copies per mL) for a minimum of one year preceding study enrollment.
Exclusion
- Opportunistic infection within the 6 months prior to study enrollment
- Active tuberculosis or other mycobacterial infection
- Uncontrolled high blood pressure or congestive heart failure class III or IV
- Systemic glucocorticoid or immunomodulator therapy within 30 days of study entry
- Prior history of Kaposi's sarcoma
- Prior history of lymphoma
- Active substance abuse within the last 30 days
- Uncontrolled psychiatric disorders, including depression
- Abnormal or inadequate liver or renal function
- Inadequate bone marrow function
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00757250
Start Date
September 1 2008
End Date
December 1 2011
Last Update
February 29 2012
Active Locations (3)
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1
LAC+USC Medical Center, Rand Schrader Clini
Los Angeles, California, United States, 90033
2
UCSD Division of Infectious Diseases
San Diego, California, United States, 92103
3
Harbor - UCLA Medical Center
Torrance, California, United States, 90502