ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01850212
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
HIV Infections

Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 476 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
Study Start Date : February 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

  • 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
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: May 9, 2013    Key Record Dates
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