A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
This study has been completed.
Sponsor:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01850212
First Posted: May 9, 2013
Last Update Posted: October 31, 2014
Information provided by (Responsible Party):
Gilead Sciences
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Purpose
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
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects |
Resource links provided by NLM:
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Femoral Neck and Spine (L1-4) T-score [ Time Frame: Day 1 ]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.
Secondary Outcome Measures:
- Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4) [ Time Frame: Day 1 ]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 ]Observed T-score for femoral neck and spine will be used to further characterize low BMD.
| Enrollment: | 476 |
| Study Start Date: | February 2013 |
| Study Completion Date: | October 2014 |
| Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Male (≥ 50 years), TDF
Male (≥ 50 years of age) on regimens containing tenofovir disoproxil fumarate (TDF)
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Male (≥ 50 years of age), Non-TDF
Male (≥ 50 years of age) on non-TDF (tenofovir disoproxil fumarate) based nucleoside reverse transcriptase inhibitors (NRTIs)
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Female (Postmenopausal), TDF
Female (postmenopausal) on regimens containing tenofovir disoproxil fumarate (TDF)
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Female (Postmenopausal), Non-TDF
Female (postmenopausal) on non-TDF (tenofovir disoproxil fumarate) based NRTIs
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Eligibility
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| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Study population of ≥ 50 year old male subjects and post-menopausal female subjects
Criteria
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
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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)
Contacts and Locations
Information from the National Library of Medicine
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): NCT01850212
Show 73 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Hiba Graham, Pharm D | Gilead Sciences |
More Information
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01850212 History of Changes |
| Other Study ID Numbers: |
GS-US-104-0423 2011-004420-35 ( EudraCT Number ) |
| First Submitted: | March 28, 2013 |
| First Posted: | May 9, 2013 |
| Last Update Posted: | October 31, 2014 |
| Last Verified: | October 2014 |
Keywords provided by Gilead Sciences:
|
Treatment Experienced Male greater than or equal to 50 years Female postmenopausal |
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 |
Tenofovir Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |