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| Sponsor: | US Biotest, Inc. |
|---|---|
| Collaborator: |
Tarix Pharmaceuticals |
| 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 |
| 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 250 Per mm3 Who Have Responded to HAART |
| 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
|
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 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 if no more than one subject in a dose cohort develops a DLT considered to be probably or definitely related to the investigational drug.
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, 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shelagh Verco, PhD | 805-595-1300 | shelagh.verco@usbiotest.com |
| 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 | |
| UCSD Division of Infectious Diseases | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Jill Kunkel 619-543-8080 ext 263 jkunkel@ucsd.edu | |
| Contact: Kathleen Nuffer 619-543-8080 knuffer@ucsd.edu | |
| Principal Investigator: Richard Haubrich, MD | |
| Harbor - UCLA Medical Center | Recruiting |
| Torrance, California, United States, 90502 | |
| Contact: Mario Guerrero 310-222-3848 ext 4 mguerrero@labiomed.org | |
| Contact: Angela Grbic agrbic@labiomed.org | |
| Principal Investigator: Eric Daar, MD | |
| Study Director: | Gere S diZerega, MD | US Biotest, Inc. |
| Principal Investigator: | Robert A Larsen, MD | University of California, Keck School of Medicine |
More Information
| Responsible Party: | US Biotest ( Gere S. diZerega, President and CEO ) |
| Study ID Numbers: | TXA127-2008-001 |
| Study First Received: | September 21, 2008 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00757250 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV AIDS Human Immunodeficiency Virus CD4+ T-lymphocytes treatment Experienced |
|
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 |
