HypogonadismHYPOGNCT02665559
Study of the Prevalence and Associated Factors With Hypogonadism in HIV + Men
An observational study of Hypogonadism and HIV, run by Tourcoing Hospital at 1 site in France.
Trial summary
Testosterone deficiency is classically associated with the development of metabolic syndrome, osteoporosis, erectile disorder and / or a reduced libido, a depressive syndrome and alteration of the quality of patients life. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Hypogonadism, HIV
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to 31 Mar 2018
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Study population: HIV-infected men, treated by cART and presenting an undetectable viral load
Who may be able to join
- Men aged 18-50 years at the inclusion visit
- Under antiretroviral treatment for more than six months with undetectable viral load (last sample older than four months before the visit of run)
- Infection by HIV-1 positive (confirmation by a full Western blot or by measurement of plasma HIV RNA prior to the inclusion)
- Lack of co-infections HBV, HCV (last negative serology older than 6 months before the screening visit inclusion)
- Consent signed by the patient and the investigator the day of the inclusion and before any examination required by the test (Article L1122-1-1 the Code of Public Health)
- Patient affiliated or beneficiary of a social security system of the European Community member countries (Article L1121-11 of the Code of Public Health).
Who cannot join
- Infection by HIV-2
- All stages of cirrhosis
- Severe renal impairment (creatinine clearance below 30 ml / min)
- Opportunistic infection during treatment or opportunistic infection in history
- Neoplastic pathology being processed
- Taken in the previous 3 months of testosterone and other anabolic agents, antiandrogens, estrogens, glucocorticoids, analog GnRH, growth hormone or human insulin-like growth factor-1 (IGF-1)
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- Pituitary, adrenal or testicular pathologies , treated or not
- Presence or history of psychotic disorder and / or high suicide risk
- Refusal to participate
- No one under safeguard justice
- Patients participating in another research evaluating other treatments and including an exclusion period ongoing at the inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversal Study, Prospective, to Evaluate the Prevalence and Factors Associated With Hypogonadism in HIV + Men
Testosterone deficiency is classically associated with the development of metabolic syndrome, osteoporosis, erectile disorder and / or a reduced libido, a depressive syndrome and alteration of the quality of patients life.
Chronicity of HIV infection leads to several disorders as fever, chronic stress, weight loss and cachexia which are the cause of hypogonadotropic hypogonadism. On the other hand, abnormal secretion of cytokines, secondary to the infection may alter the Leydig cells causing a hypergonadotropic hypogonadism and disrupts steroidogenesis. Cases of testicular invasion by lymphoma or Kaposi's syndromes have also been described.
Read more
The advent of antiretroviral therapy has reduced the prevalence of hypogonadism in patients infected with HIV that is currently about 20%. This prevalence remains about 20%, regardless of the antiretroviral therapy and CD4-T cell count.
No study to our knowledge has so far assessed exhaustively the clinical features, biological, therapeutic and paraclinical of hypotestosteronemiae while assessing the level of total serum testosterone, SHBG and serum free testosterone, among HIV infected patients in the European population.
Read the detailed description
Assess the prevalence and clinical, biological, paraclinical and therapeutic factors associated with primary or secondary hypogonadism in HIV treated and virologically suppressed patients.
- Conditions
- Hypogonadism, HIV
- Keywords
- HIV, Hypogonadism, Metabolic Syndrom, Reservoirs, Osteodensitometry, Erectil dysfonction, Depression
- Medical subject headings
- Hypogonadism, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypogonadism group | a cross-sectional and prospective study, in HIV-infected men less than 50 years old, with HIV-RNA ≤ 50 cop/mL under ART who had never presented AIDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosteron Level
Quantification of testosteron level at Day 0 of the inclusion and at Day 8 after inclusion
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2013
- Primary completionJun 2016
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine CHERET, M.D.,PhD., Study chair, Tourcoing HospitalArmelle PASQUET, M.D., Study director, Tourcoing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665559
- Sponsor's protocol ID
- HYPOGONADISME
- Acronym
- HYPOG
- Status last verified
- Jan 2016
- First submitted
- 5 Jun 2013
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: data are reported on a informatic folder centralized at Tourcoing Hospital with anonymous number for each patient Each patient receive by their own practician the biologics data
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversal Study, Prospective, to Evaluate the Prevalence and Factors Associated With Hypogonadism in HIV + Men
- ClinicalTrials.gov ID
- NCT02665559
- Acronym / sponsor ID
- HYPOG / HYPOGONADISME
- Conditions
- Hypogonadism, HIV
- Keywords
- HIV, Hypogonadism, Metabolic Syndrom, Reservoirs, Osteodensitometry, Erectil dysfonction, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 27 Jan 2016 (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.
Testosterone deficiency is classically associated with the development of metabolic syndrome, osteoporosis, erectile disorder and / or a reduced libido, a depressive syndrome and alteration of the quality of patients life.
Chronicity of HIV infection leads to several disorders as fever, chronic stress, weight loss and cachexia which are the cause of hypogonadotropic hypogonadism. On the other hand, abnormal secretion of cytokines, secondary to the infection may alter the Leydig cells causing a hypergonadotropic hypogonadism and disrupts steroidogenesis. Cases of testicular invasion by lymphoma or Kaposi's syndromes have also been described.
The advent of antiretroviral therapy has reduced the prevalence of hypogonadism in patients infected with HIV that is currently about 20%. This prevalence remains about 20%, regardless of the antiretroviral therapy and CD4-T cell count.
No study to our knowledge has so far assessed exhaustively the clinical features, biological, therapeutic and paraclinical of hypotestosteronemiae while assessing the level of total serum testosterone, SHBG and serum free testosterone, among HIV infected patients in the European population.
Detailed description
Assess the prevalence and clinical, biological, paraclinical and therapeutic factors associated with primary or secondary hypogonadism in HIV treated and virologically suppressed patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypogonadism group | – | –a cross-sectional and prospective study, in HIV-infected men less than 50 years old, with HIV-RNA ≤ 50 cop/mL under ART who had never presented AIDS |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- HIV-infected men, treated by cART and presenting an undetectable viral load
Key inclusion criteria (6 listed)
- Men aged 18-50 years at the inclusion visit
- Under antiretroviral treatment for more than six months with undetectable viral load (last sample older than four months before the visit of run)
- Infection by HIV-1 positive (confirmation by a full Western blot or by measurement of plasma HIV RNA prior to the inclusion)
- Lack of co-infections HBV, HCV (last negative serology older than 6 months before the screening visit inclusion)
- Consent signed by the patient and the investigator the day of the inclusion and before any examination required by the test (Article L1122-1-1 the Code of Public Health)
Key exclusion criteria (11 listed)
- Infection by HIV-2
- All stages of cirrhosis
- Severe renal impairment (creatinine clearance below 30 ml / min)
- Opportunistic infection during treatment or opportunistic infection in history
- Neoplastic pathology being processed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Testosteron Level
Time frame: up to 1 year
Quantification of testosteron level at Day 0 of the inclusion and at Day 8 after inclusion
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 17 Sep 2018.
- Individual participant dataSharing planned: Yes. data are reported on a informatic folder centralized at Tourcoing Hospital with anonymous number for each patient Each patient receive by their own practician the biologics data
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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.
Antoine CHERET, M.D.,PhD. study chair
Tourcoing Hospital
Armelle PASQUET, M.D. study director
Tourcoing Hospital
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 Hypogonadism and HIV, run by Tourcoing Hospital at 1 site in France.
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 6 inclusion and 11 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 17 Sep 2018. 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 France. 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?
Testosteron Level (time frame: up to 1 year). 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 17 Sep 2018.