A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01850212
First received: March 28, 2013
Last updated: July 3, 2014
Last verified: July 2014

March 28, 2013
July 3, 2014
February 2013
September 2014   (final data collection date for primary outcome measure)
Femoral Neck and Spine (L1-4) T-score [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
Femoral neck and spine (L1-4) T-score will be used to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen relative to those on any non-TDF-based regimen for HIV infection.
Femoral Neck and Spine (L1-4) T-score [ Time Frame: One Day ] [ Designated as safety issue: No ]
To characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen relative to those on any non-TDF-based regimen for HIV infection
Complete list of historical versions of study NCT01850212 on ClinicalTrials.gov Archive Site
  • Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Observed T-score for femoral neck and spine will be used to further characterize low BMD.
  • Observed -2 ≤ T-score < -1 (yes/no) for femoral neck and spine (L1-4) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Observed T-score for femoral neck and spine will be used to further characterize low BMD.
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A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

Study population of ≥ 50 year old male subjects and post-menopausal female subjects

HIV Infections
Not Provided
  • Male (≥ 50 years), TDF
    Male (≥ 50 years of age) on regimens containing tenofovir disoproxil fumarate (TDF)
  • Male (≥ 50 years of age), Non-TDF
    Male (≥ 50 years of age) on non-TDF (tenofovir disoproxil fumarate) based nucleoside reverse transcriptase inhibitors (NRTIs)
  • Female (Postmenopausal), TDF
    Female (postmenopausal) on regimens containing tenofovir disoproxil fumarate (TDF)
  • Female (Postmenopausal), Non-TDF
    Female (postmenopausal) on non-TDF (tenofovir disoproxil fumarate) based NRTIs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
480
September 2014
September 2014   (final data collection date for primary outcome measure)

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 antiretroviral (ARV) regimen for ≥ 3 years are allowed (within-class change of agents other than TDF within 3 years of study entry are permitted as specified):

    • 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 one 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 regimen to another non-TDF NRTI regimen 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 non-boosted 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 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
  • Adequate records available to evaluate medical history for the 3 years prior to study entry

Exclusion Criteria:

  • Subject has a contraindication to dual-energy X-ray absorptiometry (DEXA) scans
  • Subject has a history of osteoporosis before initiating Highly Active Antiretroviral Treatment (HAART)
Both
50 Years and older
No
Contact: Melanie Cain +44 (0) 208 587 2307 melanie.cain@gilead.com
Austria,   Belgium,   France,   Germany,   Ireland,   Italy,   Netherlands,   Poland,   Portugal,   Spain,   Switzerland,   United Kingdom
 
NCT01850212
GS-US-104-0423, 2011-004420-35
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Hiba Graham, Pharm D Gilead Sciences
Gilead Sciences
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP