To characterize the profile of low BMD in >= 50 years old male HIV-1 infected subjects andpost-menopausal female HIV-1 infected subjects taking TDF-based regimens relative tothose taking non-TDF-based regimens for HIV infection.
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The femoral neck T-score and spine (L1-4) T-score are the primary endpoints to
characterize
the low BMD (both as continuous measures).
Secondary outcome
Secondary endpoints for characterizing low BMD are:
• Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4)
• Observed -2 <= T-score < -1 (yes/no) 1 for femoral neck and spine (L1-4)
Background summary
To date, most data regarding BMD changes with HIV-1 therapy have been obtained
in
younger adults, and little is known regarding the impact of traditional risk
factors for BMD
loss in combination with HIV-1 infection and treatment including age. The
potential public
health impact of BMD changes associated with HIV-1 infection and TDF therapy
are likely
small among HIV-infected patients taking TDF-based therapy, given the low
incidence of
osteopenia and osteoporosis in patients receiving TDF and that small decreases
in BMD
observed during clinical studies of TDF were not considered clinically relevant
and were not
associated with an increased fracture risk. Clinical studies of TDF in subjects
with HIV-1
infection did not include sufficient numbers of elderly subjects to allow
evaluation of
efficacy and safety in this population. Similarly, the pharmacokinetics of TDF
have not been
evaluated in subjects >= 65 years. Limited post-marketing data for TDF in HIV-1
infected
subjects suggest that the nature and severity of spontaneously reported
possible adverse drug
reactions (ADRs) is similar in the elderly compared with younger adults, but
robust data are
not available.
This cross-sectional study will characterize BMD as assessed by DEXA scanning
in HIV-1
infected male subjects >= 50 years of age and in HIV-1 infected post-menopausal
female
subjects, both taking NRTI-containing ARV regimen. The profile of low BMD of
patients
taking TDF-based regimens relative to those taking non-TDF-based regimens will
be
characterized using a modeling approach. The impact of PI use will also be
explored.
Study objective
To characterize the profile of low BMD in >= 50 years old male HIV-1 infected
subjects and
post-menopausal female HIV-1 infected subjects taking TDF-based regimens
relative to
those taking non-TDF-based regimens for HIV infection.
Study design
Cross-sectional study of BMD as assessed by dual energy x-ray
absorptiometry (DEXA) scan in HIV-1 infected male subjects
>= 50 years of age and post-menopausal female subjects, taking
nucleoside reverse transcriptase inhibitor (NRTI)-containing
antiretroviral (ARV) regimen.
Study burden and risks
This study can have the following side-effects:
Blood sampling: Drawing blood from a vein may cause local pain, bruising,
occasional light-headedness, fainting, and very rarely, infection at the site
of the blood draw.
DEXA scans: During the DEXA scans (special type of X-ray), you will be exposed
to less radiation than occurs with a chest X-ray, DEXA scans are generally
considered to be harmless.
Condom use: It has been proven that condom use decreases the risk of spreading
HIV virus between sexually active individuals. To decrease the risk of
transmitting the virus to another individual and to decrease the risk of being
infected with a different strain of HIV, we recommend that condoms be used for
all sexual activity to include oral, vaginal, and anal sexual contact. Condom
use is recommended in addition to your current form of birth control.
During the study visit the following procedures will be performed (amongst
others):
- extended medical history (amongst others diabetes and HIV medical history,
osteopenia and osteoporosis (risk evaluation)
Lakeside Drive 333
Foster City 94404, CA
US
Lakeside Drive 333
Foster City 94404, CA
US
Listed location countries
Age
Inclusion criteria
• Must have the ability to understand and sign a written informed
consent form, which must be obtained prior to initiation of any
study procedures.
• HIV-1 infected subjects regardless of race or ethnicity
• Use of one of the following taken as a stable, continuous,
NRTI-containing ARV regimen for >= 3 years are allowed (withinclass
change of agents other than TDF within 3 years of study entry
are permitted as specified):
* a TDF plus PI/r-containing regimen, including subjects
who switched from one TDF plus PI/r regimen to
another TDF plus PI/r regimen
* a TDF plus non-PI/r-containing regimen, including
subjects who switched from a TDF plus non-PI/r
regimen to another TDF plus non-PI/r regimen
* a Non-TDF NRTI plus a PI/r -containing regimen,
including subjects who switched from one non-TDF
NRTI plus PI/r regimen to another non-TDF NRTI
regimen plus PI/r regimen
* a Non-TDF NRTI plus a non-PI/r -containing regimen,
including subjects who switched from one non-TDF
NRTI plus non-PI/r to another non-TDF plus non-PI/r
regimen
• Of note, subjects in the non-TDF groups must have never taken a
regimen that includes TDF (including previous exposure to TDF for
pre-exposure prophylaxis (PrEP))
• Subjects included in the TDF groups must have always taken a
regimen that includes TDF.
Non-PI/r agents include non-nucleoside reverse transcriptase inhibitors
(NNRTIs), integrase inhibitors, triple nucleoside inhibitors and nonboosted
protease inhibitors.
• Male subjects must be >= 50 years of age
• Female subjects must be postmenopausal. Menopause can be
assumed to have occurred in a woman when there is either:
* Appropriate medical documentation of prior complete
bilateral oophorectomy (i.e., surgical removal of the
ovaries, resulting in *surgical removal of the ovaries,
resulting in *surgical menopause* and occurring at the
age at which the procedure was performed) or
* Permanent cessation of previously occurring menses
> 12 months as a result of ovarian failure or bilateral
oophorectomy with documentation of hormonal
deficiency by a certified healthcare provided (i.e.,
*spontaneous menopause,* which occurs in the United
States at a mean age of 51.5 years).
• Documented spontaneous menopause defined as:
* Age >= 54 years with the absence of normal menses
defined as serum FSH level elevated to within the post
menopausal range based on the laboratory reference
range where the hormonal assay is performed.
* Or Age < 54 years and with the absence of normal
menses defined as a negative serum or urine human
chorionic gonadotropin (hCG) with concurrently
elevated serum FSH level in the post-menopausal range,
depressed estradiol (E2) level in the post menopausal
range, and absent serum progesterone level, based on the
laboratory reference ranges where the hormonal assays
are performed.
• Adequate records available to evaluate medical history for the
3 years prior to study entry, including:
* Prior ARV regimens and other medications
* Risk factors for osteoporosis and osteopenia
Exclusion criteria
• Subject has a contraindication to DEXA scans
• Subject has a history of osteoporosis before initiating Highly Active
Antiretroviral Treatment (HAART)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-004420-35-NL |
| CCMO | NL42245.078.12 |