| City: |
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Boston |
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State:
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MA |
| Zip Code: |
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02114 |
| Conditions: |
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HIV Infections - Menopause |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
1. Females age 45 -52.
2. 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:
1. 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.
2. Diabetes and current use of insulin, or medications known to affect glucose or
insulin levels.
3. Positive pregnancy test or recently pregnant within the past year or lactating.
4. Presence of active cancers.
5. 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).
6. Opportunistic infection within 3 months of study participation (HIV positive
subjects).
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| Study is available at: |
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Massachusetts General Hospital
Boston, MA 02114
United States
Primary Contact:
Sara E Looby, PhD, ANP
Email: slooby@partners.org
Phone: 617-726-1423
Secondary Contact:
Sara E Looby, PhD, ANP
Email: slooby@partners.org
Phone: 617-726-1423 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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