HIV InfectionsPhase 1NCT00757250
Safety Study of TXA127 to Elevate CD4+ T-Lymphocyte Counts in HIV-Infected Patients on Stable HAART Therapy
A Phase 1 study testing Angiotensin 1-7 in people with HIV Infections, run by US Biotest, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Angiotensin 1-7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2008to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Active substance abuse within the last 30 days
- Uncontrolled psychiatric disorders, including depression
- Abnormal or inadequate liver or renal function
- Inadequate bone marrow function
Trial locations and contacts
3 sites in 1 country.
United States3 sites
LAC+USC Medical Center, Rand Schrader Clini
Los Angeles, California, 90033
UCSD Division of Infectious Diseases
San Diego, California, 92103
Harbor - UCLA Medical Center
Torrance, California, 90502
About this 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
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.
Read the 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).
- Conditions
- HIV Infections
- Being tested
- Angiotensin 1-7
- Keywords
- HIV, AIDS, Human Immunodeficiency Virus, CD4+ T-lymphocytes, treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin 1-7Drug
Also called TXA127
Once daily subcutaneous injection of 50, 100, 200 or 300 mcg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose Cohort 1: 50 mcg/kg/day of TXA127 Receives: Drug: Angiotensin 1-7 |
| 2 | Experimental | Drug Cohort 2: 100 mcg/kg/day TXA127 Receives: Drug: Angiotensin 1-7 |
| 3 | Experimental | Drug Cohort 3: 200 mcg/kg/day TXA127 Receives: Drug: Angiotensin 1-7 |
| 4 | Experimental | Drug Cohort 4: 300 mcg/kg/day TXA127 Receives: 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. Receives: Drug: Angiotensin 1-7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-1 RNA viral load count
Measured: 18 weeks and 34 weeks (cohort 5)
Secondary outcomes (1)
CD4+ T-lymphocyte count
Measured: 18 weeks and 34 weeks (cohort 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Difficulty recruiting subjects to dosing cohort 5.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Biotest, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tarix Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Gere S diZerega, MD, Study director, US Biotest, Inc.Robert A Larsen, MD, Principal investigator, University of California, Keck School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757250
- Sponsor's protocol ID
- TXA127-2008-001
- Status last verified
- Feb 2012
- First submitted
- 21 Sep 2008
- Last updated
- 29 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00757250
- Acronym / sponsor ID
- TXA127-2008-001
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, Human Immunodeficiency Virus, CD4+ T-lymphocytes, treatment Experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting subjects to dosing cohort 5.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- US Biotest, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tarix Pharmaceuticals
- Study start
- Sep 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Angiotensin 1-7Dose Cohort 1: 50 mcg/kg/day of TXA127 |
| 2 | Experimental | Drug: Angiotensin 1-7Drug Cohort 2: 100 mcg/kg/day TXA127 |
| 3 | Experimental | Drug: Angiotensin 1-7Drug Cohort 3: 200 mcg/kg/day TXA127 |
| 4 | Experimental | Drug: Angiotensin 1-7Drug Cohort 4: 300 mcg/kg/day TXA127 |
| 5 | Experimental | Drug: Angiotensin 1-7Extended dosing cohort at 300mcg/kg TXA127 for 2 x 28-day treatment cycles, with an extended follow-up period to week 34. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin 1-7Also: TXA127Once daily subcutaneous injection of 50, 100, 200 or 300 mcg/kg/day | Drug | 1, 2, 3, 4, 5 |
Primary outcome
HIV-1 RNA viral load count
Time frame: 18 weeks and 34 weeks (cohort 5)
1 secondary outcome
CD4+ T-lymphocyte count
Time frame: 18 weeks and 34 weeks (cohort 5)
Results and safety
The study was stopped early (reason given: Difficulty recruiting subjects to dosing cohort 5.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gere S diZerega, MD study director
US Biotest, Inc.
Robert A Larsen, MD principal investigator
University of California, Keck School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Angiotensin 1-7 in people with HIV Infections, run by US Biotest, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty recruiting subjects to dosing cohort 5.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-1 RNA viral load count (time frame: 18 weeks and 34 weeks (cohort 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2012.