HIVPhase 4NCT01535235
ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study
A Phase 4 study testing Lisinopril in people with HIV, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators propose a proof-of-concept, pathogenesis-oriented, randomized, placebo-controlled pilot study to assess whether the addition of an angiotensin converting enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses lymphoid fibrosis, and whether this leads to more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Lisinopril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2014
- Phase
- Phase 4
- 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
- Stable HAART with maintenance of plasma HIV RNA levels below level of detection (< 40-75 copies/mL) for ≥ 12 months
- > 90% adherence to HAART within preceding 30 days
Who cannot join
- Screening systolic blood pressure < 110mm Hg or diastolic blood pressure < 60mm Hg
- Current use of any ACE inhibitor, angiotensin receptor blocker, or aldosterone antagonist
- Known diabetes mellitus or cardiovascular/kidney/collagen vascular disease
- Pregnant/breastfeeding women.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
The investigators propose a proof-of-concept, pathogenesis-oriented, randomized, placebo-controlled pilot study to assess whether the addition of an angiotensin converting enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses lymphoid fibrosis, and whether this leads to more effective HIV-specific host immune responses and an accelerated clearance of the latent reservoir.
- Conditions
- HIV
- Being tested
- Lisinopril, Placebo
- Keywords
- HIV, Lymphoid fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisinoprilDrug
Lisinopril 20mg QD x 24 weeks
PlaceboDrug
Placebo QD x24wks
| Study group | Role | What they receive |
|---|---|---|
| ACE Inhibitor | Active comparator | Active group Receives: Drug: Lisinopril |
| Placebo | Placebo comparator | Placebo group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HIV RNA (Copies/Million Rectal Cells)
Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline
Measured: 22 weeks
Secondary outcomes (1)
Change in HIV DNA (Copies/Million Rectal Cells)
Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2014
- Study completionDec 2014
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.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research
- Responsible party
- Sponsor
- Investigators
- Hiroyu Hatano, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535235
- Sponsor's protocol ID
- 11-08132
- Status last verified
- May 2016
- First submitted
- 9 Feb 2012
- Last updated
- 16 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT01535235
- Acronym / sponsor ID
- 11-08132
- Conditions
- HIV
- Keywords
- HIV, Lymphoid fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research
- Study start
- Feb 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Posted 31 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a proof-of-concept, pathogenesis-oriented, randomized, placebo-controlled pilot study to assess whether the addition of an angiotensin converting enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses lymphoid fibrosis, and whether this leads to more effective HIV-specific host immune responses and an accelerated clearance of the latent reservoir.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACE Inhibitor | Active comparator | Drug: LisinoprilActive group |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable HAART with maintenance of plasma HIV RNA levels below level of detection (< 40-75 copies/mL) for ≥ 12 months
- > 90% adherence to HAART within preceding 30 days
Key exclusion criteria (4 listed)
- Screening systolic blood pressure < 110mm Hg or diastolic blood pressure < 60mm Hg
- Current use of any ACE inhibitor, angiotensin receptor blocker, or aldosterone antagonist
- Known diabetes mellitus or cardiovascular/kidney/collagen vascular disease
- Pregnant/breastfeeding women.
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 |
|---|---|---|
| LisinoprilLisinopril 20mg QD x 24 weeks | Drug | ACE Inhibitor |
| PlaceboPlacebo QD x24wks | Drug | Placebo |
Primary outcome
Change in HIV RNA (Copies/Million Rectal Cells)
Time frame: 22 weeks
Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline
1 secondary outcome
Change in HIV DNA (Copies/Million Rectal Cells)
Time frame: 22 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hiroyu Hatano, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lisinopril in people with HIV, run by University of California, San Francisco 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 2 inclusion and 4 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 16 Jun 2016. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 31 Mar 2016). 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?
Change in HIV RNA (Copies/Million Rectal Cells) (time frame: 22 weeks). 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 16 Jun 2016.