Human Immunodeficiency VirusNCT03747003
Gonadal Function in Young to Middle Aged HIV-infected Men
An observational study of Human Immunodeficiency Virus and Hypogonadism, Male, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
HIV infection is associated to premature decline of serum testosterone. However, prevalence and biochemical characterization of hypogonadism in HIV-infected men are still to be well defined. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Human Immunodeficiency Virus, Hypogonadism, Male, Erectile Dysfunction
- How many people
- 315 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2013to 31 Dec 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: Cohort of Young-to-Middle Aged HIV-infected Patients
Who may be able to join
- Male gender
- Age 18-50 years
- HIV-infection
- Ongoing Highly Active Antiretroviral Therapy
Who cannot join
- Previous treatment with androgens, anti-androgens
- Severe liver insufficiency
- Severe renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gonadal Function in Young to Middle Aged HIV-infected Men Assessed by Isotopic Dilution-liquid Chromatography-mass Spectrometry (ID-LC-MS/MS) and Chemiluminescent Immunoassay
HIV infection is associated to premature decline of serum testosterone. However, prevalence and biochemical characterization of hypogonadism in HIV-infected men are still to be well defined. HIV-infection is strongly associated to erectile dysfunction in men, but preliminary data suggest that it is poorly associated with serum testosterone in this context.
Read the detailed description
The aim of this study is to evaluate the gonadal function of young to middle aged HIV-infected men in order to characterize hypogonadism by assessing circulating total testosterone with either Liquid Chromatography tandem Mass Spectrometry (LC-MS/MS) or chemiluminescent immunoassay. Furthermore, secondary aim is to assess the erectile function through the use of validated questionnaires (International Index of Erectile Function (IIEF) 15 and 5).
- Being tested
- No intervention is provided
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Eunuchism, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is providedOther
No intervention is provided
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected male patients | Male patients (age 18-50 years) with HIV-infection and ongoing HAART therapy No intervention is provided Receives: Other: No intervention is provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum total testosterone
From blood sample - unit of measurement ng/dL
Measured: Assessed only once at the moment of enrollment with liquid chromatography tandem mass spectrometry
Serum total testosterone
From blood sample - unit of measurement ng/dL
Measured: Assessed only once at the moment of enrollment with chemiluminiscent immunoassay
Secondary outcomes (2)
Serum free testosterone
Calculated formula (Vermeulen equation)
Measured: Calculated only once at the moment of enrollment
Score at IIEF questionnaire
Total score at erectile function domain of IIEF-15 questionnaire
Measured: Assessed only once at the moment of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start15 May 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Rochira, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747003
- Sponsor's protocol ID
- 15/13
- Status last verified
- Feb 2021
- First submitted
- 16 Nov 2018
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gonadal Function in Young to Middle Aged HIV-infected Men Assessed by Isotopic Dilution-liquid Chromatography-mass Spectrometry (ID-LC-MS/MS) and Chemiluminescent Immunoassay
- ClinicalTrials.gov ID
- NCT03747003
- Acronym / sponsor ID
- 15/13
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 15 May 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Nov 2018 (actual)
- 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 to premature decline of serum testosterone. However, prevalence and biochemical characterization of hypogonadism in HIV-infected men are still to be well defined. HIV-infection is strongly associated to erectile dysfunction in men, but preliminary data suggest that it is poorly associated with serum testosterone in this context.
Detailed description
The aim of this study is to evaluate the gonadal function of young to middle aged HIV-infected men in order to characterize hypogonadism by assessing circulating total testosterone with either Liquid Chromatography tandem Mass Spectrometry (LC-MS/MS) or chemiluminescent immunoassay. Furthermore, secondary aim is to assess the erectile function through the use of validated questionnaires (International Index of Erectile Function (IIEF) 15 and 5).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-infected male patients | – | Other: No intervention is providedMale patients (age 18-50 years) with HIV-infection and ongoing HAART therapy No intervention is provided |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Cohort of Young-to-Middle Aged HIV-infected Patients
Key inclusion criteria (4 listed)
- Male gender
- Age 18-50 years
- HIV-infection
- Ongoing Highly Active Antiretroviral Therapy
Key exclusion criteria (3 listed)
- Previous treatment with androgens, anti-androgens
- Severe liver insufficiency
- Severe renal insufficiency
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 |
|---|---|---|
| No intervention is providedNo intervention is provided | Other | HIV-infected male patients |
Primary outcome
Serum total testosterone
Time frame: Assessed only once at the moment of enrollment with liquid chromatography tandem mass spectrometry
From blood sample - unit of measurement ng/dL
Serum total testosterone
Time frame: Assessed only once at the moment of enrollment with chemiluminiscent immunoassay
From blood sample - unit of measurement ng/dL
2 secondary outcomes
Serum free testosterone
Time frame: Calculated only once at the moment of enrollment
Score at IIEF questionnaire
Time frame: Assessed only once at the moment of enrollment
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 9 Feb 2021.
- Individual participant dataSharing planned: No
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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 Human Immunodeficiency Virus and Hypogonadism, Male, run by Azienda Ospedaliero-Universitaria di Modena 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 4 inclusion and 3 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 9 Feb 2021. 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?
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?
Serum total testosterone (time frame: Assessed only once at the moment of enrollment with liquid chromatography tandem mass spectrometry). The study lists 2 primary outcomes in all. 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 9 Feb 2021.