Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
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ClinicalTrials.gov Identifier: NCT01142817 |
Recruitment Status
:
Completed
First Posted
: June 11, 2010
Last Update Posted
: August 7, 2013
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Condition or disease |
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HIV Infections Menopause |
Study Type : | Observational |
Actual Enrollment : | 66 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Metabolic and Psychological Changes Associated With Menopause Among Women With HIV |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |
Group/Cohort |
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HIV Postive Women
Women living with HIV who meet study eligibility criteria
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Healthy Control Subjects
Women without HIV who meet study eligibility criteria
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- Bone Mineral Density [ Time Frame: baseline to 12 months ]Measurement of bone density at the toal body, lumbar spine and total hip
- Body Composition [ Time Frame: baseline to 12 months ]Total body fat and abdominal fat measurement, and total lean mass measurement
- Lipid Levels [ Time Frame: baseline to 12 months ]Lipid levels include total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride levels
- Glucose Metabolism [ Time Frame: baseline to 12 months ]Includes fasting glucose and insulin levels
- Depression [ Time Frame: baseline to 12 months ]Depressive symptoms assessed by the Centers for Epidemiologic Studies Depression Scale (CES-D)
- Quality of Life [ Time Frame: baseline to 12 months ]Assessed by the Utian Quality of Life Scale
- Vasomotor Symptoms [ Time Frame: Baseline to 12 months ]Assessed by the Menopause Rating Scale, includes hot flashes, mood, sleep, genitourinary symptoms, and sexual function
- Systemic Inflammation (as it relates to cardiovascular risk/body composition changes) [ Time Frame: Baseline to 12 months ]Assessment of inflammatory biomarkers and cytokines including CRP,IL-6, TNF-α, and PAI-1, as well as adiponectin.
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 45 Years to 52 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
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Opportunistic infection within 3 months of study participation (HIV positive subjects).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142817
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Sara E Looby, PhD, ANP | Massachusetts General Hospital |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sara E. Dolan Looby, PhD, ANP-BC, Principal Investigator, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01142817 History of Changes |
Other Study ID Numbers: |
2009P-001315 |
First Posted: | June 11, 2010 Key Record Dates |
Last Update Posted: | August 7, 2013 |
Last Verified: | August 2013 |
Keywords provided by Sara E. Dolan Looby, PhD, ANP-BC, Massachusetts General Hospital:
HIV Women Menopause Dyslipidemia Bone Mineral Density |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |