HIV InfectionsNCT01142817
Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
An observational study of HIV Infections and Menopause, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will investigate the prevalence and extent of both metabolic and psychosocial changes associated with the menopause transition over 1 year among women with HIV compared to women without HIV of similar age, weight, menstrual status, and ethnic background. Read more about this study
- Who is it for?
- Ages 45 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Menopause
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to May 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 45 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female subjects in the perimenopausal transition will be recruited via referral by infectious disease providers, newspaper advertisement, posted flyers, community based programs at local AIDS Service Organizations and Partners subject recruitment broadcast at Massachusetts General Hospital (MGH). The HIV negative control subjects will be recruited through advertisements, flyers, and email announcements. Both HIV positive and negative subjects will be recruited from the same neighborhoods to ensure similar demographic characteristics.
Who may be able to join
- Females age 45 -52.
- Females in the perimenopausal transition characterized by the presence of abnormal menstrual function, defined as less than 3 periods in the past 3 months, 1 cycle >60 days in length in the prior 6 months, or irregular menses in 2 or more cycles within the past 6 months. Women who have been amenorrheic for >12 months will not be eligible. 3. Women with HIV must have previously documented HIV and be receiving a stable treatment regimen for > 3 months.
Who cannot join
- Use of estrogen, combination hormone replacement therapy, oral contraceptive pills/patches, Depo Provera, glucocorticoids, testosterone, growth hormone or other anabolic steroids within the past 6 months.
- Diabetes and current use of insulin, or medications known to affect glucose or insulin levels.
- Positive pregnancy test or recently pregnant within the past year or lactating.
- Presence of active cancers.
- Current use of bisphosphonates, or a diagnosis of Paget's disease or other illnesses known to affect bone (Use of calcium and Vitamin D will be permitted).
- Opportunistic infection within 3 months of study participation (HIV positive subjects).
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This study will investigate the prevalence and extent of both metabolic and psychosocial changes associated with the menopause transition over 1 year among women with HIV compared to women without HIV of similar age, weight, menstrual status, and ethnic background. It is hypothesized that HIV positive women will demonstrate increased abdominal fat, abnormal cholesterol and blood sugar levels, reduced bone density, and greater psychosocial challenges than HIV negative women during the menopause transition.
Read the detailed description
Treatment with combination antiretroviral therapy (ART) has resulted in substantial improvement in survival among women living with HIV in the United States, many of whom have entered or will soon enter the menopause transition. Significant changes are seen across the menopause transition among women without HIV including increased abdominal fat and waist circumference, reduced muscle mass, and changes in lipids, glucose metabolism and bone density. HIV and potentially ART use have been associated with similar manifestations such as reduced bone density, changes in lipid and glucose metabolism, and body composition, though little is known regarding how the virus may influence or exacerbate such changes across the menopause transition. In addition to metabolic factors, menopause has been associated with changes in mood state, decreased quality of life, and presence of vasomotor symptoms among women without HIV. Psychosocial indices, such as depression and decreased quality of life are common among women with HIV, and may manifest or worsen during the menopause transition. However, research investigating the presence and acuity of these symptoms among women with HIV during menopause is limited.
- Conditions
- HIV Infections, Menopause
- Keywords
- HIV, Women, Menopause, Dyslipidemia, Bone Mineral Density
- Medical subject headings
- HIV Infections, Dyslipidemias
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 |
|---|---|---|
| HIV Postive Women | Women living with HIV who meet study eligibility criteria | |
| Healthy Control Subjects | Women without HIV who meet study eligibility criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Measurement of bone density at the toal body, lumbar spine and total hip
Measured: baseline to 12 months
Secondary outcomes (7)
Body Composition
Total body fat and abdominal fat measurement, and total lean mass measurement
Measured: baseline to 12 months
Lipid Levels
Lipid levels include total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride levels
Measured: baseline to 12 months
Glucose Metabolism
Includes fasting glucose and insulin levels
Measured: baseline to 12 months
Depression
Depressive symptoms assessed by the Centers for Epidemiologic Studies Depression Scale (CES-D)
Measured: baseline to 12 months
Quality of Life
Assessed by the Utian Quality of Life Scale
Measured: baseline to 12 months
Vasomotor Symptoms
Assessed by the Menopause Rating Scale, includes hot flashes, mood, sleep, genitourinary symptoms, and sexual function
Measured: Baseline to 12 months
Systemic Inflammation (as it relates to cardiovascular risk/body composition changes)
Assessment of inflammatory biomarkers and cytokines including CRP,IL-6, TNF-α, and PAI-1, as well as adiponectin.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara E. Dolan Looby, PhD, ANP-BC, Massachusetts General Hospital
- Investigators
- Sara E Looby, PhD, ANP, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142817
- Sponsor's protocol ID
- 2009P-001315
- Status last verified
- Aug 2013
- First submitted
- 10 Jun 2010
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Looby SE. Menopause-associated metabolic manifestations and symptomatology in HIV infection: a brief review with research implications. J Assoc Nurses AIDS Care. 2012 May-Jun;23(3):195-203. doi: 10.1016/j.jana.2011.06.008. Epub 2011 Sep 15.
PubMed 21924646Looby SE, Shifren J, Corless I, Rope A, Pedersen MC, Joffe H, Grinspoon S. Increased hot flash severity and related interference in perimenopausal human immunodeficiency virus-infected women. Menopause. 2014 Apr;21(4):403-9. doi: 10.1097/GME.0b013e31829d4c4c.
PubMed 23820600
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
- ClinicalTrials.gov ID
- NCT01142817
- Acronym / sponsor ID
- 2009P-001315
- Conditions
- HIV Infections, Menopause
- Keywords
- HIV, Women, Menopause, Dyslipidemia, Bone Mineral Density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Jun 2010 (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.
This study will investigate the prevalence and extent of both metabolic and psychosocial changes associated with the menopause transition over 1 year among women with HIV compared to women without HIV of similar age, weight, menstrual status, and ethnic background. It is hypothesized that HIV positive women will demonstrate increased abdominal fat, abnormal cholesterol and blood sugar levels, reduced bone density, and greater psychosocial challenges than HIV negative women during the menopause transition.
Detailed description
Treatment with combination antiretroviral therapy (ART) has resulted in substantial improvement in survival among women living with HIV in the United States, many of whom have entered or will soon enter the menopause transition. Significant changes are seen across the menopause transition among women without HIV including increased abdominal fat and waist circumference, reduced muscle mass, and changes in lipids, glucose metabolism and bone density. HIV and potentially ART use have been associated with similar manifestations such as reduced bone density, changes in lipid and glucose metabolism, and body composition, though little is known regarding how the virus may influence or exacerbate such changes across the menopause transition. In addition to metabolic factors, menopause has been associated with changes in mood state, decreased quality of life, and presence of vasomotor symptoms among women without HIV. Psychosocial indices, such as depression and decreased quality of life are common among women with HIV, and may manifest or worsen during the menopause transition. However, research investigating the presence and acuity of these symptoms among women with HIV during menopause is limited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV Postive Women | – | –Women living with HIV who meet study eligibility criteria |
| Healthy Control Subjects | – | –Women without HIV who meet study eligibility criteria |
Who may qualify
- Ages
- 45 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female subjects in the perimenopausal transition will be recruited via referral by infectious disease providers, newspaper advertisement, posted flyers, community based programs at local AIDS Service Organizations and Partners subject recruitment broadcast at Massachusetts General Hospital (MGH). The HIV negative control subjects will be recruited through advertisements, flyers, and email announcements. Both HIV positive and negative subjects will be recruited from the same neighborhoods to ensure similar demographic characteristics.
Key inclusion criteria (2 listed)
- Females age 45 -52.
- Females in the perimenopausal transition characterized by the presence of abnormal menstrual function, defined as less than 3 periods in the past 3 months, 1 cycle >60 days in length in the prior 6 months, or irregular menses in 2 or more cycles within the past 6 months. Women who have been amenorrheic for >12 months will not be eligible. 3. Women with HIV must have previously documented HIV and be receiving a stable treatment regimen for > 3 months.
Key exclusion criteria (7 listed)
- Use of estrogen, combination hormone replacement therapy, oral contraceptive pills/patches, Depo Provera, glucocorticoids, testosterone, growth hormone or other anabolic steroids within the past 6 months.
- Diabetes and current use of insulin, or medications known to affect glucose or insulin levels.
- Positive pregnancy test or recently pregnant within the past year or lactating.
- Presence of active cancers.
- Current use of bisphosphonates, or a diagnosis of Paget's disease or other illnesses known to affect bone (Use of calcium and Vitamin D will be permitted).
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
Bone Mineral Density
Time frame: baseline to 12 months
Measurement of bone density at the toal body, lumbar spine and total hip
7 secondary outcomes
Body Composition
Time frame: baseline to 12 months
Lipid Levels
Time frame: baseline to 12 months
Glucose Metabolism
Time frame: baseline to 12 months
Depression
Time frame: baseline to 12 months
Quality of Life
Time frame: baseline to 12 months
Vasomotor Symptoms
Time frame: Baseline to 12 months
Systemic Inflammation (as it relates to cardiovascular risk/body composition changes)
Time frame: Baseline to 12 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 7 Aug 2013.
- Background: PubMed 21924646Looby SE. Menopause-associated metabolic manifestations and symptomatology in HIV infection: a brief review with research implications. J Assoc Nurses AIDS Care. 2012 May-Jun;23(3):195-203. doi: 10.1016/j.jana.2011.06.008. Epub 2011 Sep 15.
- Derived from this study: PubMed 23820600Looby SE, Shifren J, Corless I, Rope A, Pedersen MC, Joffe H, Grinspoon S. Increased hot flash severity and related interference in perimenopausal human immunodeficiency virus-infected women. Menopause. 2014 Apr;21(4):403-9. doi: 10.1097/GME.0b013e31829d4c4c.
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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.
Sara E Looby, PhD, ANP principal investigator
Massachusetts General 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 HIV Infections and Menopause, run by Massachusetts General Hospital at 1 site in United States.
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 2 inclusion and 7 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 7 Aug 2013. 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 United States. 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?
Bone Mineral Density (time frame: baseline to 12 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 NCT01142817, which also lists 2 linked publications.
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 7 Aug 2013.