HIV InfectionPhase 2MATHNCT01088295
HIV and Fat Accumulation
A Phase 2 study testing Telmisartan in people with HIV Infection, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This is a research study to see whether fat accumulation either under the skin or in the body's organs, for example, the liver, improves in men and women who take a drug called telmisartan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Telmisartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 positive men and women 18 years and older
- HIV-1 infection as documented by ELISA and confirmed by Western blot or plasma HIV-1 RNA >2000 on two occasions
- Documented central fat accumulation
- HIV RNA documented to be less than 50 copies/mL at screening and undetectable by assay of choice for at least 12 weeks prior to entry
- Current antiretroviral therapy with a suppressive, highly active antiretroviral regimen.
- Systolic BP >115mmHg.
- Ability and willingness to provide informed consent
Who cannot join
- Pregnancy (current or within the last 6 months) or nursing
- Uncontrolled hypertension
- Prohibited concomitant medications
- Subjects with untreated hyperlipidemia must be willing to abstain from initiating therapy for the 24 week duration fo the study.
- Subjects undergoing treatment for diabetes with oral hypoglycemic agents must be willing to remain on their current dose of insulin sensitizing agents for the duration of the study.
- Known, untreated renal artery stenosis
Show all 10Show fewer
- Unstable coronary artery disease/angina or decompensated congestive heart failure.
- Any history of intolerance to any member of the angiotensin receptor blocker class of agents.
- Need for ongoing potassium supplementation.
- Screening laboratory values as follows ANC (absolute neutrophil count) <750 cells/mm3 Hemoglobin <10 gm/dL ClCr (creatinine clearance)< 30 ml/min (estimated by Cockcroft-Gault equation) AST (aspartate aminotransferase) or ALT (alanine aminotransferase) > 3 x ULN (upper limit of normal)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Abnormalities, Telmisartan and HIV Infection
This is a research study to see whether fat accumulation either under the skin or in the body's organs, for example, the liver, improves in men and women who take a drug called telmisartan. The investigators will be looking at how the amount of fat in the body changes when HIV-positive persons on effective anti-HIV therapy take telmisartan. The investigators will be using a CT scan to make this comparison. Telmisartan is not an HIV medication. It is a medication used to treat blood pressure, but has been shown to decrease fat in the organs in people both with and without high blood pressure. The study involves 8 visits over a period of about 24 weeks.
- Conditions
- HIV Infection
- Being tested
- Telmisartan
- Keywords
- Metabolic, HIV, Fat accumulation, AIDS, Metabolic abnormalities in HIV infection, HIV Infections
- 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.
TelmisartanDrug
Also called Micardis
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | Telmisartan 40mg po daily for 24 weeks Receives: Drug: Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Change in Visceral Adipose Tissue (VAT) Volume
VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- California HIV/AIDS Research Program
- Responsible party
- Sponsor
- Investigators
- Jordan Lake, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088295
- Sponsor's protocol ID
- MATH
- Acronym
- MATH
- Status last verified
- Jan 2019
- First submitted
- 16 Mar 2010
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lake JE, Tseng CH, Currier JS. A pilot study of telmisartan for visceral adiposity in HIV infection: the metabolic abnormalities, telmisartan, and HIV infection (MATH) trial. PLoS One. 2013;8(3):e58135. doi: 10.1371/journal.pone.0058135. Epub 2013 Mar 14.
PubMed 23516440
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Abnormalities, Telmisartan and HIV Infection
- ClinicalTrials.gov ID
- NCT01088295
- Acronym / sponsor ID
- MATH / MATH
- Conditions
- HIV Infection
- Keywords
- Metabolic, HIV, Fat accumulation, AIDS, Metabolic abnormalities in HIV infection, HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- California HIV/AIDS Research Program
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Posted 18 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to see whether fat accumulation either under the skin or in the body's organs, for example, the liver, improves in men and women who take a drug called telmisartan. The investigators will be looking at how the amount of fat in the body changes when HIV-positive persons on effective anti-HIV therapy take telmisartan. The investigators will be using a CT scan to make this comparison. Telmisartan is not an HIV medication. It is a medication used to treat blood pressure, but has been shown to decrease fat in the organs in people both with and without high blood pressure. The study involves 8 visits over a period of about 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: TelmisartanTelmisartan 40mg po daily for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV positive men and women 18 years and older
- HIV-1 infection as documented by ELISA and confirmed by Western blot or plasma HIV-1 RNA >2000 on two occasions
- Documented central fat accumulation
- HIV RNA documented to be less than 50 copies/mL at screening and undetectable by assay of choice for at least 12 weeks prior to entry
- Current antiretroviral therapy with a suppressive, highly active antiretroviral regimen.
Key exclusion criteria (10 listed)
- Pregnancy (current or within the last 6 months) or nursing
- Uncontrolled hypertension
- Prohibited concomitant medications
- Subjects with untreated hyperlipidemia must be willing to abstain from initiating therapy for the 24 week duration fo the study.
- Subjects undergoing treatment for diabetes with oral hypoglycemic agents must be willing to remain on their current dose of insulin sensitizing agents for the duration of the study.
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 |
|---|---|---|
| TelmisartanAlso: Micardis | Drug | Telmisartan |
Primary outcome
Median Change in Visceral Adipose Tissue (VAT) Volume
Time frame: Baseline and 24 weeks
VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23516440Lake JE, Tseng CH, Currier JS. A pilot study of telmisartan for visceral adiposity in HIV infection: the metabolic abnormalities, telmisartan, and HIV infection (MATH) trial. PLoS One. 2013;8(3):e58135. doi: 10.1371/journal.pone.0058135. Epub 2013 Mar 14.
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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.
Jordan Lake, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telmisartan in people with HIV Infection, run by University of California, Los Angeles at 1 site 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 7 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: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Median Change in Visceral Adipose Tissue (VAT) Volume (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01088295, which also lists 1 linked publication.
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 4 Feb 2019.