Human Immunodeficiency Virus InfectionPhase 4NCT01869634
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
A Phase 4 study testing darunavir with ritonavir and fixed-dose viread+emtricitabine daily in people with Human Immunodeficiency Virus Infection, run by University of California, Davis at 1 site in United States.
Trial summary
Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation (CD)4+ T-cell populations, normalization of systemic immune activation, and improved HIV-associated cardiovascular disease (CVD) risk. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus Infection
- What is being tested?
- darunavir with ritonavir and fixed-dose viread+emtricitabine daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2016
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to sign consent form
- Naïve to ART (remote ART use >5 years will be considered on a case by case basis)
- No known GI or cardiovascular disease
- Between the ages of 18 and 60
- No active opportunistic infections or therapy for acute OI within 30 days of entry. Subjects can be on secondary prophylaxis with a history of AIDS defining illness.
- All women of childbearing potential (WCBP) must have a negative urine pregnancy test before any of the invasive or radiation exposure study procedures.
- Normal population should be free of chronic metabolic conditions such as diabetes, hypercholesterolemia, or coronary artery disease
- There are no CD4+ T-cell count or HIV plasma viral load restrictions.
Who cannot join
- Abnormal coagulation parameters (PT>1.2 upper limit of normal (ULN))
- Thrombocytopenia (platelet count <50.000 within 6 weeks)
- Contra-indications to upper endoscopy or conscious sedation
- Anemia (>grade 1 [appendix 1])
- Aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy.
- Renal insufficiency (serum Creatinine >1.2 ULN)
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- History of chronic proteinuria that could impact viread use.
- Allergy to contrast used for CT angiography
- Requirement to take medications that are contraindicated with study ART regimen.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Sacramento, California, 95617
About this study
Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation (CD)4+ T-cell populations, normalization of systemic immune activation, and improved HIV-associated cardiovascular disease (CVD) risk.
Read the detailed description
Rationale Infection with HIV causes significant morbidity and mortality, even among individuals who are virologically suppressed with combination anti-retroviral therapy (ART). ART is effective in prolonging life and enabling individuals who are HIV positive to live near-normal life spans. However, these individuals are increasingly developing a number of chronic diseases of aging, such as atherosclerotic cardiovascular disease (ASCVD). The proposed studies will examine the role of highly active antiretroviral therapy in restoring the mucosal immunity and the systemic effect on immune activation, bacterial translocation, and change in HIV-associated cardiovascular disease risk.
- Conditions
- Human Immunodeficiency Virus Infection
- Being tested
- darunavir with ritonavir and fixed-dose viread+emtricitabine daily
- Keywords
- HIV, cardiovascular risk, systemic immune activation
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darunavir with ritonavir and fixed-dose viread+emtricitabine dailyDrug
Also called darunavir (Prezista®) 800 mg with ritonavir 100 mg and Truvada® to be taken once daily
| Study group | Role | What they receive |
|---|---|---|
| HIV positive naive to ART | Active comparator | HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART. Receives: Drug: darunavir with ritonavir and fixed-dose viread+emtricitabine daily |
| normal control volunteers | No intervention | HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV
CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV.
Measured: Baseline, 12 months
Secondary outcomes (1)
Change in Percentage of Total Artery Diameter
computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2016
- Study completionDec 2016
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 Human Immunodeficiency Virus InfectionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869634
- Sponsor's protocol ID
- 394080
- Other IDs
- IIS RFA _Asmuth:TMC114HIV2029
- Status last verified
- Feb 2020
- First submitted
- 1 Jun 2013
- Last updated
- 4 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
- ClinicalTrials.gov ID
- NCT01869634
- Acronym / sponsor ID
- 394080
- Conditions
- Human Immunodeficiency Virus Infection
- Keywords
- HIV, cardiovascular risk, systemic immune activation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Posted 4 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation (CD)4+ T-cell populations, normalization of systemic immune activation, and improved HIV-associated cardiovascular disease (CVD) risk.
Detailed description
Rationale Infection with HIV causes significant morbidity and mortality, even among individuals who are virologically suppressed with combination anti-retroviral therapy (ART). ART is effective in prolonging life and enabling individuals who are HIV positive to live near-normal life spans. However, these individuals are increasingly developing a number of chronic diseases of aging, such as atherosclerotic cardiovascular disease (ASCVD). The proposed studies will examine the role of highly active antiretroviral therapy in restoring the mucosal immunity and the systemic effect on immune activation, bacterial translocation, and change in HIV-associated cardiovascular disease risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV positive naive to ART | Active comparator | Drug: darunavir with ritonavir and fixed-dose viread+emtricitabine dailyHIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART. |
| normal control volunteers | No intervention | –HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing to sign consent form
- Naïve to ART (remote ART use >5 years will be considered on a case by case basis)
- No known GI or cardiovascular disease
- Between the ages of 18 and 60
- No active opportunistic infections or therapy for acute OI within 30 days of entry. Subjects can be on secondary prophylaxis with a history of AIDS defining illness.
Key exclusion criteria (9 listed)
- Abnormal coagulation parameters (PT>1.2 upper limit of normal (ULN))
- Thrombocytopenia (platelet count <50.000 within 6 weeks)
- Contra-indications to upper endoscopy or conscious sedation
- Anemia (>grade 1 [appendix 1])
- Aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy.
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 |
|---|---|---|
| darunavir with ritonavir and fixed-dose viread+emtricitabine dailyAlso: darunavir (Prezista®) 800 mg with ritonavir 100 mg and Truvada® to be taken once daily | Drug | HIV positive naive to ART |
Primary outcome
Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV
Time frame: Baseline, 12 months
CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV.
1 secondary outcome
Change in Percentage of Total Artery Diameter
Time frame: Baseline, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 darunavir with ritonavir and fixed-dose viread+emtricitabine daily in people with Human Immunodeficiency Virus Infection, run by University of California, Davis 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 8 inclusion and 9 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 Mar 2020. 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 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 4 Mar 2020). 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?
Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV (time frame: Baseline, 12 months). 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 4 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.