HIV-1 InfectionPhase 4NCT01529749
Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated
A Phase 4 study testing EFV/FTC/TDF + Losartan, EFV/FTC/TDF and FTC/TDF + MK-0518 in people with HIV-1 Infection, run by Felipe Garcia at 1 site in Spain.
Trial summary
This is a open controlled trial in which 48 HIV-1 patients successfully treated with EFV/FTC/TDF will be randomized to one of 4 groups in equal proportion between arms (1:1). The four arms are as follows: Arm I: EFV / FTC / TDF (n = 12) Arm II: EFV / FTC / TDF + LST (n = 12) Arm III: FTC / TDF + MK-0518 (n = 12) Arm… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- EFV/FTC/TDF + Losartan, EFV/FTC/TDF and FTC/TDF + MK-0518
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years.
- Patients with HIV infection in antiretroviral treatment with EFV / FTC / TDF with undetectable viral load (VL <37 copies) for at least 48 weeks.
- Nadir CD4 +> 250 cells/mm3.
- Patients, properly informed, give their written consent to participate in the study.
Who cannot join
- Criteria for patients with AIDS.
- Patients with active opportunistic diseases.
- Patients coinfected with HCV.
- Patients without tonsillar tissue.
- Treatment with other drugs receptor antagonists or angiotensin II converting enzyme inhibitors, angiotensin II.
- Kidney failure.(Glomerular Filtration Rate (GFR < 60 mL/mn)
Show all 13Show fewer
- Severe liver failure (PT> 60% ).
- Pregnant women
- Known hypersensitivity or contraindication to any study drug.
- determination of blood pressure (BP) <100/60 mmHg
- Hyponatremia with serum Na numbers <132 Meq / l
- History of chronic vomiting the last 6 months
- History of chronic diarrhea the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation
This is a open controlled trial in which 48 HIV-1 patients successfully treated with EFV/FTC/TDF will be randomized to one of 4 groups in equal proportion between arms (1:1). The four arms are as follows:
Arm I: EFV / FTC / TDF (n = 12) Arm II: EFV / FTC / TDF + LST (n = 12) Arm III: FTC / TDF + MK-0518 (n = 12) Arm IV: FTC / TDF + LST + MK-0518 (n = 12)
Read more
The allocation will take place in two phases:
Phase I: 24 patients 1:1 receiving EFV/FTC/TDF vs. EFV/FTC/TDF + Losartan
If losartan arm shows benefits we will proceed to the second phase:
Phase II: 24 patients 1:1 to receive FTC/TDF+ MK-0518 versus FTC/TDF + MK-0518 + losartan.
Patients will be followed up during 12 months to determinate the proportion of patients with decreased collagen deposition in TL equal to or greater than 50%.
- Conditions
- HIV-1 Infection
- Being tested
- EFV/FTC/TDF + Losartan, EFV/FTC/TDF, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFV/FTC/TDF + LosartanDrug
EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
EFV/FTC/TDFDrug
600/200/245 mg, od, oral
FTC/TDF + MK-0518Drug
FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+LosartanDrug
FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
| Study group | Role | What they receive |
|---|---|---|
| EFV/FTC/TDF | Active comparator | Not described Receives: Drug: EFV/FTC/TDF |
| EFV/FTC/TDF + Losartan | Experimental | Not described Receives: Drug: EFV/FTC/TDF + Losartan |
| FTC/TDF + MK-0518 | Experimental | Not described Receives: Drug: FTC/TDF + MK-0518 |
| FTC/TDF+MK-0518+Losartan | Experimental | Not described Receives: Drug: FTC/TDF+MK-0518+Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.
Measured: 48 weeks
Secondary outcomes (16)
Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.
Measured: 48 weeks
Proportion of Patients With Changes in the Levels of CRP in Different Groups.
Measured: 48 weeks
Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.
Measured: 48 weeks
Proportion of Patients With Increased CD4 in Peripheral Blood.
Measured: 48 weeks
Proportion of Patients With Increased CD4 in Lymphatic Tissue.
Measured: week 48
Proportion of Patients With Undetectable Plasma Viral Load in Different Groups
Measured: 48 weeks
Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups
Measured: week 48
Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.
Measured: 48 weeks
Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.
Measured: 48 weeks
Proportion of Patients With Changes in Levels of Metalloproteinases
Measured: 48 weeks
Proportion of Patients With Changes in Levels of beta2-microglobulin.
Measured: 48 weeks
Proportion of Patients With Changes in Levels of CSF Cells.
Measured: 48 weeks
Proportion of Patients With Changes in Levels of Proteins.
Measured: 48 weeks
Proportion of Patients With Improvement in Neuropsychological Test
Measured: 48 weeks
Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.
Measured: up to 48 weeks
Changes in CD4 CD38+ HLADR+ (%)
Marker of activation in CD4 T cells. This Outcome Measure is reporting a change in the percentage of CD4 CD38+ HLADR+ T cells at 48 months minus the percentage at 0 weeks (baseline)
Measured: 0, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2012
- Study completionFeb 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 HIV-1 InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Felipe Garcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Felipe Garcia, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529749
- Sponsor's protocol ID
- HIV-IMMUNESARTAN
- Other IDs
- 2011-002071-42
- Status last verified
- Jun 2019
- First submitted
- 8 Feb 2012
- Last updated
- 2 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation
- ClinicalTrials.gov ID
- NCT01529749
- Acronym / sponsor ID
- HIV-IMMUNESARTAN
- Conditions
- HIV-1 Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Felipe GarciaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Posted 2 Aug 2019
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 open controlled trial in which 48 HIV-1 patients successfully treated with EFV/FTC/TDF will be randomized to one of 4 groups in equal proportion between arms (1:1). The four arms are as follows:
Arm I: EFV / FTC / TDF (n = 12) Arm II: EFV / FTC / TDF + LST (n = 12) Arm III: FTC / TDF + MK-0518 (n = 12) Arm IV: FTC / TDF + LST + MK-0518 (n = 12)
The allocation will take place in two phases:
Phase I: 24 patients 1:1 receiving EFV/FTC/TDF vs. EFV/FTC/TDF + Losartan
If losartan arm shows benefits we will proceed to the second phase:
Phase II: 24 patients 1:1 to receive FTC/TDF+ MK-0518 versus FTC/TDF + MK-0518 + losartan.
Patients will be followed up during 12 months to determinate the proportion of patients with decreased collagen deposition in TL equal to or greater than 50%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EFV/FTC/TDF | Active comparator | Drug: EFV/FTC/TDF |
| EFV/FTC/TDF + Losartan | Experimental | Drug: EFV/FTC/TDF + Losartan |
| FTC/TDF + MK-0518 | Experimental | Drug: FTC/TDF + MK-0518 |
| FTC/TDF+MK-0518+Losartan | Experimental | Drug: FTC/TDF+MK-0518+Losartan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years.
- Patients with HIV infection in antiretroviral treatment with EFV / FTC / TDF with undetectable viral load (VL <37 copies) for at least 48 weeks.
- Nadir CD4 +> 250 cells/mm3.
- Patients, properly informed, give their written consent to participate in the study.
Key exclusion criteria (13 listed)
- Criteria for patients with AIDS.
- Patients with active opportunistic diseases.
- Patients coinfected with HCV.
- Patients without tonsillar tissue.
- Treatment with other drugs receptor antagonists or angiotensin II converting enzyme inhibitors, angiotensin II.
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 |
|---|---|---|
| EFV/FTC/TDF + LosartanEFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12. | Drug | EFV/FTC/TDF + Losartan |
| EFV/FTC/TDF600/200/245 mg, od, oral | Drug | EFV/FTC/TDF |
| FTC/TDF + MK-0518FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral | Drug | FTC/TDF + MK-0518 |
| FTC/TDF+MK-0518+LosartanFTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12. | Drug | FTC/TDF+MK-0518+Losartan |
Primary outcome
Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.
Time frame: 48 weeks
16 secondary outcomes
Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.
Time frame: 48 weeks
Proportion of Patients With Changes in the Levels of CRP in Different Groups.
Time frame: 48 weeks
Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.
Time frame: 48 weeks
Proportion of Patients With Increased CD4 in Peripheral Blood.
Time frame: 48 weeks
Proportion of Patients With Increased CD4 in Lymphatic Tissue.
Time frame: week 48
Proportion of Patients With Undetectable Plasma Viral Load in Different Groups
Time frame: 48 weeks
Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups
Time frame: week 48
Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.
Time frame: 48 weeks
Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.
Time frame: 48 weeks
Proportion of Patients With Changes in Levels of Metalloproteinases
Time frame: 48 weeks
Proportion of Patients With Changes in Levels of beta2-microglobulin.
Time frame: 48 weeks
Proportion of Patients With Changes in Levels of CSF Cells.
Time frame: 48 weeks
Proportion of Patients With Changes in Levels of Proteins.
Time frame: 48 weeks
Proportion of Patients With Improvement in Neuropsychological Test
Time frame: 48 weeks
Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.
Time frame: up to 48 weeks
Changes in CD4 CD38+ HLADR+ (%)
Time frame: 0, 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- 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 EFV/FTC/TDF + Losartan, EFV/FTC/TDF and FTC/TDF + MK-0518 in people with HIV-1 Infection, run by Felipe Garcia at 1 site in Spain.
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 4 inclusion and 13 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 2 Aug 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 Spain. 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 2 Aug 2019). 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?
Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue. (time frame: 48 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 2 Aug 2019.