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

Sponsors and Collaborators:	US Biotest, Inc. Tarix Pharmaceuticals, Inc.
Information provided by:	US Biotest, Inc.
ClinicalTrials.gov Identifier:	NCT00757250

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Angiotensin 1-7	Phase I

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Evaluation of the Safety and Biologic Activity of TXA127 in HIV-Infected Subjects With CD4+ T-Lymphocyte Counts Less Than 200 Per mm3 Who Have Responded to HAART

Further study details as provided by US Biotest, Inc.:

Primary Outcome Measures:

HIV-1 RNA viral load count [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

CD4+ T-lymphocyte count [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	September 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Dose Cohort 1: 50 mcg/kg/day of TXA127	Drug: Angiotensin 1-7 Once daily subcutaneous injection of 50, 100, 200 or 300 mcg/kg/day
2: Experimental Drug Cohort 2: 100 mcg/kg/day TXA127	Drug: Angiotensin 1-7 Once daily subcutaneous injection of 50, 100, 200 or 300 mcg/kg/day
3: Experimental Drug Cohort 3: 200 mcg/kg/day TXA127	Drug: Angiotensin 1-7 Once daily subcutaneous injection of 50, 100, 200 or 300 mcg/kg/day
4: Experimental Drug Cohort 4: 300 mcg/kg/day TXA127	Drug: Angiotensin 1-7 Once daily subcutaneous injection of 50, 100, 200 or 300 mcg/kg/day

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 200 per mm3 who have responded to highly active retroviral therapy (HAART). The study has been designed to determine the maximum tolerated dose (MTD) of TXA127 in this subject population. This study will also obtain safety and biologic activity information about the subcutaneous injection of TXA127.

Four escalating dosing cohorts will be examined to determine the MTD. The four dosing cohorts will receive 50, 100, 200 and 300 mcg/kg of TXA127 by subcutaneous injection daily for 14 days then 14 days without treatment. The 28 days will be defined as one cycle. The cycle of therapy will be repeated once, for a total of two courses of treatment. Between 2 and 6 subjects will be enrolled in a dose cohort depending on the incidence of dose-limiting toxicities (DLT)among the within-cohort subject population. Dose escalation to the next cohort of subjects will be permitted according to following criteria.

A standard Simon Phase I dose escalation trial has been proposed. The MTD will have been exceeded if the proportion of subjects that develops the same or similar study-drug-related, dose-limiting toxicity (DLT) in an assigned dosing schedule equals 2/2, 2/3, 2/4, 2/5, and 2/6 subjects. The MTD is defined as the largest dose that <2 of 6 subjects experiences a DLT. Dose-limiting toxicity is defined as a study-drug-related grade 3 or 4 adverse event (AE).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 200 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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757250

Contacts

Contact: Rebecca Weegar

805-595-1300

Rebecca.Weegar@USBiotest.com

Locations

United States, California
LAC+USC Medical Center, Rand Schrader Clini	Recruiting
Los Angeles, California, United States, 90033
Contact: Connie Funk, RN 323-343-8282 Funk@USC.edu
Principal Investigator: Robert A Larsen, MD
Sub-Investigator: Alejandro Sanchez, MD

Sponsors and Collaborators

US Biotest, Inc.

Tarix Pharmaceuticals, Inc.

Investigators

Study Director:	Gere S diZerega, MD	US Biotest, Inc.
Principal Investigator:	Robert A Larsen, MD	University of California, Keck School of Medicine

More Information

No publications provided

Responsible Party:	US Biotest ( Gere S. diZerega, President and CEO )
Study ID Numbers:	TXA127-2008-001
Study First Received:	September 21, 2008
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00757250 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by US Biotest, Inc.:

HIV
AIDS
Human Immunodeficiency Virus
CD4+ T-lymphocytes
treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome

Cardiovascular Agents
Antihypertensive Agents
Angiotensin I (1-7)
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Cardiovascular Agents
Antihypertensive Agents
Infection
Angiotensin I (1-7)

Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009