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

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

Condition	Phase
HIV Infections	Phase 4


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:

MedlinePlus related topics: Bone Density HIV/AIDS Minerals

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


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
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

Eligibility


Ages Eligible for Study:	50 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	March 28, 2013
Last Updated:	October 30, 2014
Health Authority:	Austria: Austrian Medicines and Medical Devices Agency Belgium: Federal Agency for Medicines and Health Products, FAMHP France: Agence Nationale de Sécurité du Médicament et des produits de santé Germany: Federal Institute for Drugs and Medical Devices Ireland: Irish Medicines Board Italy: The Italian Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Portugal: INFARMED, National Authority of Medicines and Health Products, IP Spain: Agencia Española de Medicamentos y Productos Sanitarios Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on September 28, 2016