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

February 27, 2012 updated by: US Biotest, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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.

Five escalating dosing cohorts will be examined to determine the MTD. The first four dosing cohorts will receive 50, 100, 200 and 300 mcg/kg of TXA127 by subcutaneous injection daily for 14 days, followed by 14 days without treatment. These 28 days will be defined as one cycle. The cycle of therapy will be repeated once, for a total of two courses of treatment. The 5th dosing cohort will receive 300 mcg/kg of TXA127 by subcutaneous injection daily for 28 days, then 14 days without treatment followed by an additional 28 days of TXA127 administration. Dose escalation to the next cohort of subjects will be permitted to the next higher dosing level provided the following criteria have been met.

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).

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • LAC+USC Medical Center, Rand Schrader Clini
      • San Diego, California, United States, 92103
        • UCSD Division of Infectious Diseases
      • Torrance, California, United States, 90502
        • Harbor - UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
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
Other Names:
  • TXA127
EXPERIMENTAL: 2
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
Other Names:
  • TXA127
EXPERIMENTAL: 3
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
Other Names:
  • TXA127
EXPERIMENTAL: 4
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
Other Names:
  • TXA127
EXPERIMENTAL: 5
Extended dosing cohort at 300mcg/kg TXA127 for 2 x 28-day treatment cycles, with an extended follow-up period to week 34.
Drug: Angiotensin 1-7
Once daily subcutaneous injection of 50, 100, 200 or 300 mcg/kg/day
Other Names:
  • TXA127

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV-1 RNA viral load count
Time Frame: 18 weeks and 34 weeks (cohort 5)
18 weeks and 34 weeks (cohort 5)

Secondary Outcome Measures

Outcome Measure
Time Frame
CD4+ T-lymphocyte count
Time Frame: 18 weeks and 34 weeks (cohort 5)
18 weeks and 34 weeks (cohort 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Biotest, Inc.

Collaborators

Tarix Pharmaceuticals

Investigators

  • Principal Investigator: Robert A Larsen, MD, University of California, Keck School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

September 21, 2008

First Submitted That Met QC Criteria

September 21, 2008

First Posted (ESTIMATE)

September 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 29, 2012

Last Update Submitted That Met QC Criteria

February 27, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TXA127-2008-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Angiotensin 1-7

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe