Safety Study of TXA127 to Elevate CD4+ T-Lymphocyte Counts in HIV-Infected Patients on Stable HAART Therapy

Stopped early · Phase 1

Conditions studied: HIV Infections

In brief

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 human immunodeficiency virus who are taking highly active anti-retroviral therapy.

Key facts

Study ID

NCT00757250

Run by

US Biotest, Inc.

People needed

13

Starts

2008-09-01

Expected to finish

2011-12-01

Last updated by the study team

2012-02-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• LAC+USC Medical Center, Rand Schrader Clini — Los Angeles, California, United States
• UCSD Division of Infectious Diseases — San Diego, California, United States
• Harbor - UCLA Medical Center — Torrance, California, United States

Full record on ClinicalTrials.gov

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