HIV InfectionNCT02097381
Study of Recovery of Intestinal CD4+ and Th17 T Cells in HIV-infected Individuals on Short-term Antiretroviral Therapy
A study testing Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir in people with HIV Infection, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
HIV infection is associated with a state of chronic, generalized immune activation that has been shown in many studies to be a key predictor of progression to AIDS. The molecular, cellular, and pathophysiological mechanisms underlying the HIV-associated immune activation are complex and still poorly studied. 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?
- Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2010to Dec 2014
- Phase
- Interventional
- 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
- naïve for antiretroviral treatment
- met the criteria to start cART according to International Guidelines
- written informed consent signed
Who cannot join
- treatment with glucocorticosteroids and any immune modulating medication for more than seven days in the previous month
- any past or current systemic malignancy, history of inflammatory diseases of the small or large intestine
- pregnancy
- anemia, use of anticoagulants, and any contraindications to phlebotomy or colonoscopy.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy
Rome, RM, 00161
About this study
Official title: HIV Infection and Gut Mucosal Immune Function: Longitudinal Analyses of Intestinal CD4+ and Th17 T Cells in HIV-infected Individuals on Short-term Antiretroviral Therapy
HIV infection is associated with a state of chronic, generalized immune activation that has been shown in many studies to be a key predictor of progression to AIDS. The molecular, cellular, and pathophysiological mechanisms underlying the HIV-associated immune activation are complex and still poorly studied. There is, however, growing consensus that both viral and host factors contribute to this phenotype, with emphasis on the role played by the mucosal immune dysfunction (and consequent microbial translocation). Moreover if it is known that in HIV-infected individuals, a severe depletion of intestinal cluster of differentiation 4 (CD4+) T-cells, is associated with loss of epithelium integrity, microbial translocation and systemic immune activation, the kinetics of intestinal CD4+ T-cell reconstitution under combined antiretroviral therapy (cART) remains poorly understood.
This study sought to evaluate the reconstitution of intestinal CD4+ T-cells, including Th1 and Th17, in blood and colon samples collected from HIV-infected individuals before and after a short term cART.
- Conditions
- HIV Infection
- Being tested
- Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir
- Keywords
- HIV infection, GUT, microbial translocation, chronic inflammation, antiretroviral therapy, cART, HAART, Th17, Th1, CD4+
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/RitonavirDrug
Also called Truvada, Prezista, Kaletra, Norvir
Conventional antiretroviral therapy started in naïve patients for antiretroviral treatment that met the criteria to start cART according to International Guidelines.
The antiretroviral treatment consisted in a tenofovir-emtricitabine NRTI backbone (TDF/FTC, 300/200 mg/ml, once a day) plus boosted protease inhibitor, lopinavir/ritonavir (LPV/r, 400/100 mg twice a day) or darunavir/ritonavir (DRV/r 800/100mg once a day).
| Study group | Role | What they receive |
|---|---|---|
| naïve for cART that met the criteria to start treatment | Other | patients naïve for antiretroviral treatment that met the criteria to start cART according to International Guidelines.
These patients will be studied for primary and secondary outcomes after a short term antiretroviral therapy. Receives: Drug: Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of number of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in colon samples between T0 (before start of cARV) and T1 (after 6 months of cARV)
recovery of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in gut mucosa after 6 months of cARV)
Measured: 6 months
Secondary outcomes (1)
Difference of number of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in blood samples between T0 (before start of cARV) and T1 (after 6 months of cARV)
recovery of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in peripheral blood after 6 months of cARV)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startApr 2010
- Primary completionMar 2014
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 Roma La SapienzaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Superiore di Sanità
- Responsible party
- Principal investigator, Giancarlo Ceccarelli, University of Roma La Sapienza
- Investigators
- Vincenzo Vullo, MD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097381
- Sponsor's protocol ID
- DPHID-UniRoma01
- Status last verified
- Mar 2014
- First submitted
- 17 Mar 2014
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
d'Ettorre G, Baroncelli S, Micci L, Ceccarelli G, Andreotti M, Sharma P, Fanello G, Fiocca F, Cavallari EN, Giustini N, Mallano A, Galluzzo CM, Vella S, Mastroianni CM, Silvestri G, Paiardini M, Vullo V. Reconstitution of intestinal CD4 and Th17 T cells in antiretroviral therapy suppressed HIV-infected subjects: implication for residual immune activation from the results of a clinical trial. PLoS One. 2014 Oct 23;9(10):e109791. doi: 10.1371/journal.pone.0109791. eCollection 2014.
PubMed 25340778
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Infection and Gut Mucosal Immune Function: Longitudinal Analyses of Intestinal CD4+ and Th17 T Cells in HIV-infected Individuals on Short-term Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT02097381
- Acronym / sponsor ID
- DPHID-UniRoma01
- Conditions
- HIV Infection
- Keywords
- HIV infection, GUT, microbial translocation, chronic inflammation, antiretroviral therapy, cART, HAART, Th17
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Istituto Superiore di Sanità
- Study start
- Apr 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 Mar 2014 (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.
HIV infection is associated with a state of chronic, generalized immune activation that has been shown in many studies to be a key predictor of progression to AIDS. The molecular, cellular, and pathophysiological mechanisms underlying the HIV-associated immune activation are complex and still poorly studied. There is, however, growing consensus that both viral and host factors contribute to this phenotype, with emphasis on the role played by the mucosal immune dysfunction (and consequent microbial translocation). Moreover if it is known that in HIV-infected individuals, a severe depletion of intestinal cluster of differentiation 4 (CD4+) T-cells, is associated with loss of epithelium integrity, microbial translocation and systemic immune activation, the kinetics of intestinal CD4+ T-cell reconstitution under combined antiretroviral therapy (cART) remains poorly understood.
This study sought to evaluate the reconstitution of intestinal CD4+ T-cells, including Th1 and Th17, in blood and colon samples collected from HIV-infected individuals before and after a short term cART.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| naïve for cART that met the criteria to start treatment | Other | Drug: Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavirpatients naïve for antiretroviral treatment that met the criteria to start cART according to International Guidelines. These patients will be studied for primary and secondary outcomes after a short term antiretroviral therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- naïve for antiretroviral treatment
- met the criteria to start cART according to International Guidelines
- written informed consent signed
Key exclusion criteria (4 listed)
- treatment with glucocorticosteroids and any immune modulating medication for more than seven days in the previous month
- any past or current systemic malignancy, history of inflammatory diseases of the small or large intestine
- pregnancy
- anemia, use of anticoagulants, and any contraindications to phlebotomy or colonoscopy.
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 |
|---|---|---|
| Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/RitonavirAlso: Truvada, Prezista, Kaletra, NorvirConventional antiretroviral therapy started in naïve patients for antiretroviral treatment that met the criteria to start cART according to International Guidelines. The antiretroviral treatment consisted in a tenofovir-emtricitabine NRTI backbone (TDF/FTC, 300/200 mg/ml, once a day) plus boosted protease inhibitor, lopinavir/ritonavir (LPV/r, 400/100 mg twice a day) or darunavir/ritonavir (DRV/r 800/100mg once a day). | Drug | naïve for cART that met the criteria to start treatment |
Primary outcome
Difference of number of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in colon samples between T0 (before start of cARV) and T1 (after 6 months of cARV)
Time frame: 6 months
recovery of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in gut mucosa after 6 months of cARV)
1 secondary outcome
Difference of number of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in blood samples between T0 (before start of cARV) and T1 (after 6 months of cARV)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
- Derived from this study: PubMed 25340778d'Ettorre G, Baroncelli S, Micci L, Ceccarelli G, Andreotti M, Sharma P, Fanello G, Fiocca F, Cavallari EN, Giustini N, Mallano A, Galluzzo CM, Vella S, Mastroianni CM, Silvestri G, Paiardini M, Vullo V. Reconstitution of intestinal CD4 and Th17 T cells in antiretroviral therapy suppressed HIV-infected subjects: implication for residual immune activation from the results of a clinical trial. PLoS One. 2014 Oct 23;9(10):e109791. doi: 10.1371/journal.pone.0109791. eCollection 2014.
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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.
Vincenzo Vullo, MD principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir in people with HIV Infection, run by University of Roma La Sapienza at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 27 Mar 2014. 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 Italy. 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.
Are results available for this study?
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?
Difference of number of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in colon samples between T0 (before start of cARV) and T1 (after 6 months of cARV) (time frame: 6 months). 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 NCT02097381, 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 27 Mar 2014.