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Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV) (BLIR-HIV)

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ClinicalTrials.gov Identifier: NCT01228318
Recruitment Status : Completed
First Posted : October 26, 2010
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ighovwerha Ofotokun, Emory University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: HIV Infection
Bone Loss
Osteopenia
Osteoporosis
Intervention: Drug: Zoledronic acid

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
At the Grady Hospital Infectious Disease Clinic 343 subjects were assessed for eligibility and 280 were excluded. 63 viremic treatment-naïve adult HIV-infected subjects were randomized in a double-blinded, placebo-controlled study (ART+placebo N=29; ART+Zoledronic acid N=34). Participants were enrolled between January 2011 and August 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Zoledronic Acid

Participants in this arm received a 5 milligrams (mg)/100 milliliter (mL) solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel.

Study visits occurred at 12, 24, 48, 96, and 144 weeks.

Placebo

Participants in the placebo arm received a placebo to match the study drug, containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered intravenously over 15-30 minutes under the supervision of study personnel.

Study visits occurred at 12, 24, 48, 96, and 144 weeks.


Participant Flow:   Overall Study
    Zoledronic Acid   Placebo
STARTED   34   29 
COMPLETED   30   22 
NOT COMPLETED   4   7 
Clinic no show to receive intervention                1                0 
Unable to contact                2                5 
Moved                0                2 
Incarcerated                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zoledronic Acid Participants in this arm received a 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel.
Placebo Participants in the placebo arm received a placebo to match the study drug, containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered intravenously over 15-30 minutes under the supervision of study personnel.
Total Total of all reporting groups

Baseline Measures
   Zoledronic Acid   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   29   63 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      34 100.0%      29 100.0%      63 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      27  79.4%      23  79.3%      50  79.4% 
Male      7  20.6%      6  20.7%      13  20.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2   5.9%      0   0.0%      2   3.2% 
Not Hispanic or Latino      32  94.1%      29 100.0%      61  96.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      27  79.4%      26  89.7%      53  84.1% 
White      7  20.6%      3  10.3%      10  15.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   34   29   63 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Median (Full Range)
 24.4 
 (18.9 to 41.2) 
 23.8 
 (16.9 to 38.7) 
 23.8 
 (16.9 to 41.2) 
Cluster of differentiation 4 (CD4) T-cell count 
[Units: cells/uL]
Median (Full Range)
 91.5 
 (5 to 239) 
 117 
 (3 to 574) 
 101 
 (3 to 574) 
HIV-1 Viral Load 
[Units: Log10 copies/ml]
Median (Full Range)
 4.97 
 (3.69 to 6.44) 
 4.93 
 (2.51 to 6.06) 
 4.96 
 (2.51 to 6.44) 
Weight 
[Units: Kilograms]
Median (Full Range)
 72.9 
 (49.8 to 118.2) 
 73.3 
 (54.9 to 107.2) 
 73.3 
 (49.8 to 118.2) 
Age 
[Units: Years]
Median (Full Range)
 38 
 (30 to 50) 
 37 
 (30 to 51) 
 38 
 (30 to 51) 
Height 
[Units: Inches]
Median (Full Range)
 69 
 (61 to 76) 
 70 
 (61 to 77) 
 70 
 (61 to 77) 


  Outcome Measures

1.  Primary:   Baseline-Adjusted Means for C-terminal Telopeptide of Collagen (CTx) Levels   [ Time Frame: Baseline, Week 12 through Week 144 ]

2.  Secondary:   Baseline-Adjusted Means of Osteocalcin   [ Time Frame: Baseline, Week 144 ]

3.  Other Pre-specified:   Baseline-Adjusted Means of Dual-energy X-ray Absorptiometry (DXA)   [ Time Frame: Baseline, Week 144 ]

4.  Post-Hoc:   Percentage of Participants With Virological Suppression by Week 144   [ Time Frame: Week 144 ]

5.  Post-Hoc:   CD4 T Cell Count   [ Time Frame: Baseline, Week 144 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This single site proof-of-concept phase 2b study had a small sample size & a 144-week study duration so it could not evaluate the impact of the intervention on long-term bone outcomes. The population enrolled limited the generalization of findings.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Igho Ofotokun, MD, MSc
Organization: Emory University
phone: 404-616-0659
e-mail: iofotok@emory.edu


Publications of Results:
Other Publications:

Responsible Party: Ighovwerha Ofotokun, Emory University
ClinicalTrials.gov Identifier: NCT01228318     History of Changes
Other Study ID Numbers: IRB00038739
BLIR-HIV ( Other Identifier: Other )
First Submitted: October 23, 2010
First Posted: October 26, 2010
Results First Submitted: March 27, 2018
Results First Posted: June 25, 2018
Last Update Posted: June 25, 2018