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

NCT00757250 | Terminated Phase 1 DMC

• 1 other identifier: TXA127-2008-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• HIV-1 RNA viral load count

  18 weeks and 34 weeks (cohort 5)

Secondary Outcomes (1)

• CD4+ T-lymphocyte count

  18 weeks and 34 weeks (cohort 5)

Study Arms (5)

1

EXPERIMENTAL

Dose Cohort 1: 50 mcg/kg/day of TXA127

Drug: Angiotensin 1-7

2

EXPERIMENTAL

Drug Cohort 2: 100 mcg/kg/day TXA127

Drug: Angiotensin 1-7

3

EXPERIMENTAL

Drug Cohort 3: 200 mcg/kg/day TXA127

Drug: Angiotensin 1-7

4

EXPERIMENTAL

Drug Cohort 4: 300 mcg/kg/day TXA127

Drug: Angiotensin 1-7

5

EXPERIMENTAL

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

Interventions

Angiotensin 1-7 DRUG

Once daily subcutaneous injection of 50, 100, 200 or 300 mcg/kg/day

Also known as: TXA127

1; 2; 3; 4; 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• US Biotest, Inc.: lead
• Tarix Pharmaceuticals: collaborator

Study Sites (3)

LAC+USC Medical Center, Rand Schrader Clini

Los Angeles, California, 90033, United States

Location

UCSD Division of Infectious Diseases

San Diego, California, 92103, United States

Location

Harbor - UCLA Medical Center

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

angiotensin I (1-7)

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Gere S diZerega, MD

  US Biotest, Inc.

  STUDY DIRECTOR

• Robert A Larsen, MD

  University of California, Keck School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2008
• First Posted: September 23, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 29, 2012

Record last verified: 2012-02

Locations

US (3)