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

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Biotest, Inc.
• Collaborator: Tarix Pharmaceuticals
• Treatments: Angiotensin I (1-7)

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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