HIV InfectionNCT01679067
Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients
An observational study of HIV Infection, run by Clara Lehmann at 1 site in Germany.
Trial summary
To date, despite the known benefits of antiretroviral therapy (ART), many HIV-infected people are presenting late with very low CD4+ T-cells levels below 350/ul. These patients are more likely to be diagnosed with opportunistic infections, their risk of death is higher and their rate of immunological improvement is… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- colonoscopy with endoscopic biopsies
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Jun 2013
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: prospective longitudinal non- controlled phase IV study, 30 patients
Who may be able to join
- Documented HIV infection
- Patients naive to antiretroviral treatment
- Age older than 18 years
- Indication for initiation of ART
- Informed consent
Who cannot join
- Patients on antiretroviral treatment
- No informed consent
- Estimated life expectancy <1 year
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Longitudinal Study of Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients Before and During Antiretroviral Therapy (ART)
To date, despite the known benefits of antiretroviral therapy (ART), many HIV-infected people are presenting late with very low CD4+ T-cells levels below 350/ul. These patients are more likely to be diagnosed with opportunistic infections, their risk of death is higher and their rate of immunological improvement is slower (Mussini C et al., 2008). These patients often present a real challenge due to their advanced clinical status (Borghi V et al., 2008). Unfortunately, little is known about the clinical presentation of these patients, their responses to antiretroviral treatment and especially about the changes in the adaptive and innate immunity of the GALT.
Read the detailed description
The investigator proposes to evaluate the virological, immunological and clinical outcomes of ART in HIV-1 infected 'late presenters'. The investigator further wants to investigate the longitudinal dynamics of the innate and adaptive immunity restoration in the GALT and peripheral blood of HIV infected patients under ART. In particular the investigators want to longitudinally assess DCs, NK-cells, CD4+ T-cells und CD45RO+-T-cells as well as the levels of IFNγ, IFNα, TNFα, and IL-12 in the GALT and peripheral blood by flow cytometry and by real-time PCR and correlate these data with laboratory and clinical parameters.
The investigators expect that this longitudinal study and experiments outlined in the protocol will provide valuable information about several important issues of the clinical outcome of patients under ART as well as understanding immunopathology during HIV-infection.
- Conditions
- HIV Infection
- Being tested
- colonoscopy with endoscopic biopsies
- Keywords
- HIV, GALT
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopy with endoscopic biopsiesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| HIV-GALT | Not described Receives: Procedure: colonoscopy with endoscopic biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
restoration of CD4 + T-cells in the GALT with ART
Measured: 6 months
Secondary outcomes (2)
Function of Dendritic Cells (DC) in the GALT with ART
Functional characterization of DCs (IFNγ, IFNα) of DCs in the GALT
Measured: 6 months
Functional characterization of NK-cells in the GALT with ART
Functional characterization on NK- cells (TNFα, and IL-12) in the GALT with ART
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 posted5 Sep 2012 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clara Lehmann
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor-investigator, Clara Lehmann, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679067
- Sponsor's protocol ID
- GALT-HIV
- Status last verified
- Jan 2016
- First submitted
- 31 Aug 2012
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Longitudinal Study of Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients Before and During Antiretroviral Therapy (ART)
- ClinicalTrials.gov ID
- NCT01679067
- Acronym / sponsor ID
- GALT-HIV
- Conditions
- HIV Infection
- Keywords
- HIV, GALT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clara LehmannUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Sep 2012 (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.
To date, despite the known benefits of antiretroviral therapy (ART), many HIV-infected people are presenting late with very low CD4+ T-cells levels below 350/ul. These patients are more likely to be diagnosed with opportunistic infections, their risk of death is higher and their rate of immunological improvement is slower (Mussini C et al., 2008). These patients often present a real challenge due to their advanced clinical status (Borghi V et al., 2008). Unfortunately, little is known about the clinical presentation of these patients, their responses to antiretroviral treatment and especially about the changes in the adaptive and innate immunity of the GALT.
Detailed description
The investigator proposes to evaluate the virological, immunological and clinical outcomes of ART in HIV-1 infected 'late presenters'. The investigator further wants to investigate the longitudinal dynamics of the innate and adaptive immunity restoration in the GALT and peripheral blood of HIV infected patients under ART. In particular the investigators want to longitudinally assess DCs, NK-cells, CD4+ T-cells und CD45RO+-T-cells as well as the levels of IFNγ, IFNα, TNFα, and IL-12 in the GALT and peripheral blood by flow cytometry and by real-time PCR and correlate these data with laboratory and clinical parameters.
The investigators expect that this longitudinal study and experiments outlined in the protocol will provide valuable information about several important issues of the clinical outcome of patients under ART as well as understanding immunopathology during HIV-infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-GALT | – | Procedure: colonoscopy with endoscopic biopsies |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- prospective longitudinal non- controlled phase IV study, 30 patients
Key inclusion criteria (5 listed)
- Documented HIV infection
- Patients naive to antiretroviral treatment
- Age older than 18 years
- Indication for initiation of ART
- Informed consent
Key exclusion criteria (4 listed)
- Patients on antiretroviral treatment
- No informed consent
- Estimated life expectancy <1 year
- Age <18 years
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 |
|---|---|---|
| colonoscopy with endoscopic biopsies | Procedure or surgery | HIV-GALT |
Primary outcome
restoration of CD4 + T-cells in the GALT with ART
Time frame: 6 months
2 secondary outcomes
Function of Dendritic Cells (DC) in the GALT with ART
Time frame: 6 months
Functional characterization of NK-cells in the GALT with ART
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
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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?
An observational study of HIV Infection, run by Clara Lehmann at 1 site in Germany.
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 5 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 13 Jan 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
restoration of CD4 + T-cells in the GALT with ART (time frame: 6 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 13 Jan 2016.