Eligibility Details:
Inclusion Criteria:
To be eligible to participate in this study, INDIVIDUALS WITH HIV must meet all of the
following criteria:
1. Male or female, aged ≥18 years.
2. HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western
blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA,
or a second antibody test by a method other than ELISA is acceptable as an alternative
confirmatory test.
3. Body mass index ≥25 kg/m2.
4. Waist circumference and waist-to-hip ratio >95 cm and >0.94 cm, respectively, for men,
and >94 cm and >0.88 cm, respectively, for women occurring in the context of HIV
treatment.
5. Subjective evidence of increased abdominal girth occurring after initiation of HIV
treatment.
6. HIV-1 RNA <400 copies/mL for ≥6 months.
7. Receiving a stable antiretroviral regimen for at least the last 12 weeks prior to
study entry with cumulative duration of 1 year of treatment at the time of study
entry.
8. Provision of signed and dated informed consent form and is capable of reading and
comprehending the informed consent.
9. Stated willingness to comply with all study procedures and availability for the
duration of the study.
10. All women of child-bearing potential (WOCBP) must have a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72
hours prior to start of study medication. WOCBP is defined as any female who has
experienced menarche and who has not undergone successful surgical sterilization
(hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not
postmenopausal (defined as amenorrhea 12 consecutive months), or is on hormone
replacement therapy (HRT) with documented plasma follicle-stimulating hormone level 35
mIU/mL. Women who are using oral, implanted, or injectable contraceptive hormones or
mechanical products such as an intrauterine device or barrier methods (diaphragm,
condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner
is sterile (e.g., vasectomy), should be considered of child-bearing potential.
11. Female subjects who are not of reproductive potential (have reached menopause or
undergone hysterectomy, bilateral oophorectomy or tubal ligation) or whose male
partner has undergone successful vasectomy with resulting azoospermia or has
azoospermia for any other reason, are eligible without requiring the use of
contraception. Patient-reported history of menopause, sterilization, and azoospermia
is considered acceptable documentation.
12. All subjects must not participate in a conception process (e.g. active attempt to
become pregnant or to impregnate, sperm donation, in vitro fertilization), and if
participating in sexual activity that could lead to pregnancy, the female subject/male
partner must use condoms (male or female) in addition to one of the following forms of
contraception while on study: either a spermicidal agent, diaphragm, cervical cap,
IUD, or hormonal-based contraception.
13. Have no plans to alter antiretroviral therapy, or to undergo any weight loss program,
formal exercise training or surgery during the study period, or initiate
structured/strategic antiretroviral treatment interruptions.
To be eligible to participate in this study, CONTROLS WITHOUT HIV must meet all of the
following criteria:
1. Male or female, aged ≥18 years.
2. Documentation of HIV negative test by any FDA-approved HIV testing kit within 30 days
prior to study entry.
3. Waist circumference and waist-to-hip ration >95 cm and >0.94 cm, respectively, for
men, and >94 cm and >0.88 cm, respectively, for women.
4. Body mass index ≥25 kg/m2.
5. Provision of signed and dated informed consent form and is capable of reading and
comprehending the informed consent.
6. Stated willingness to comply with all study procedures and availability for the
duration of the study.
7. All women of child-bearing potential (WOCBP) must have a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72
hours prior to start of study medication. WOCBP is defined as any female who has
experienced menarche and who has not undergone successful surgical sterilization
(hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not
postmenopausal (defined as amenorrhea 12 consecutive months), or is on hormone
replacement therapy (HRT) with documented plasma follicle-stimulating hormone level 35
mIU/mL. Women who are using oral, implanted, or injectable contraceptive hormones or
mechanical products such as an intrauterine device or barrier methods (diaphragm,
condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner
is sterile (e.g., vasectomy), should be considered of child-bearing potential.
8. Female subjects who are not of reproductive potential (have reached menopause or
undergone hysterectomy, bilateral oophorectomy or tubal ligation) or whose male
partner has undergone successful vasectomy with resulting azoospermia or has
azoospermia for any other reason, are eligible without requiring the use of
contraception. Patient-reported history of menopause, sterilization, and azoospermia
is considered acceptable documentation.
9. Acceptable documentation of menopause, sterilization, and azoospermia is patient
reported history.
10. All subjects must not participate in a conception process (e.g. active attempt to
become pregnant or to impregnate, sperm donation, in vitro fertilization), and if
participating in sexual activity that could lead to pregnancy, the female subject/male
partner must use condoms (male or female) in addition to one of the following forms of
contraception while on study: either a spermicidal agent, diaphragm, cervical cap,
IUD, or hormonal-based contraception.
11. Have no plans to undergo any weight loss program, formal exercise training or surgery
during the study period.
***Selection of controls will be made so that the group matches the HIV-infected group by
age, gender and body mass index***
Exclusion Criteria:
Main exclusion criteria (FOR BOTH GROUPS):
1. Known cardiovascular disease or diagnosed diabetes. If on metformin without a diabetes
diagnoses metformin use has to be constant, uninterrupted for 6 months prior to entry.
2. Any active or chronic uncontrolled inflammatory condition, infection or cancer.
3. Women who are pregnant or breastfeeding.
4. Women with a positive pregnancy test on enrollment or prior to study drug
administration.
5. A clinically-relevant illness within 14 days prior to study entry not explicitly
excluded by the protocol, a physical or psychiatric disability, or a laboratory
abnormality that might place the subject at increased risk by being exposed to the
medications in this study or which might confound the interpretation of this
investigation.
6. Active gastrointestinal symptom Grade >1 within the last month.
7. Regular use of immunomodulators/agents which could impact inflammation. Regular use of
NSAIDS allowed if constant, uninterrupted for 6 months and no plans to alter. Statin
use must also be constant, uninterrupted for 6 months prior to study entry. Thyroid
medication allowed unless diagnosed with uncontrolled thyroid disease.
8. Inability to communicate effectively with study personnel.
9. Use of megestrol acetate, testosterone, or any steroid use beyond normal amounts found
in the body within 6 months of study, or intend to start.
10. Glomerular filtration rate <50 cc/min/1.73 m2.
11. Hemoglobin <10 g/dL.
12. Elevated lipase level >1.5 upper limit of normal
13. AST AND ALT >2.5x upper limit of normal.
14. Use of growth hormone or growth hormone-releasing hormone in the last year, or intent
to start.
15. History of excessive alcohol use (on average 2 or more drinks a day) , pancreatitis,
thyroid cancer, or a diagnosis of multiple endocrine neoplasia (MEN) syndrome type 2.
16. History of gallbladder or bile duct disease or cholelithiasis.
17. History of lactose intolerance or inability to consume milk products will be
exclusionary for participation in the mixed-meal tolerance test portion of the study.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
