Trial Outcomes & Findings for Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV) (NCT NCT01228318)

Last Updated: 2018-06-26

Results Overview

Serum C-terminal telopeptide of collagen (CTx) levels through week 144 were examined by evaluating the baseline-adjusted means. The baseline-adjusted CTx mean is defined as the predicted response value obtained by fitting the regression equation for each treatment arm at the mean baseline value for the 2 treatment arms. The adjusted means were estimated using analysis of covariance at each scheduled clinical visit. The expected outcome is that HIV-infected individuals will display increased indices of bone resorption (CTx) as a result of diminished bone mineral density (BMD). Lower CTx values indicate that better maintenance of bone mineral density.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

Baseline, Week 12 through Week 144

Results posted on

2018-06-26

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	34	29
Overall Study COMPLETED	30	22
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Clinic no show to receive intervention	1	0
Overall Study Unable to contact	2	5
Overall Study Moved	0	2
Overall Study Incarcerated	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zoledronic Acid n=34 Participants 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 n=29 Participants 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 n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	29 participants n=7 Participants	63 participants n=5 Participants
Body Mass Index (BMI)	24.4 kg/m^2 n=5 Participants	23.8 kg/m^2 n=7 Participants	23.8 kg/m^2 n=5 Participants
Cluster of differentiation 4 (CD4) T-cell count	91.5 cells/uL n=5 Participants	117 cells/uL n=7 Participants	101 cells/uL n=5 Participants
HIV-1 Viral Load	4.97 log10 copies/ml n=5 Participants	4.93 log10 copies/ml n=7 Participants	4.96 log10 copies/ml n=5 Participants
Weight	72.9 kilograms n=5 Participants	73.3 kilograms n=7 Participants	73.3 kilograms n=5 Participants
Age	38 years n=5 Participants	37 years n=7 Participants	38 years n=5 Participants
Height	69 inches n=5 Participants	70 inches n=7 Participants	70 inches n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12 through Week 144

Population: Participants with CTx measurements at the indicated week are included in this analysis.

Outcome measures

Outcome measures
Measure	Zoledronic Acid n=31 Participants Subjects in this arm will receive 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel. Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes. b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.	Placebo n=26 Participants Subjects in the placebo arm will receive placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered iv over 15-30 minutes under the supervision of study personnel. Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes. b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.
Baseline-Adjusted Means for C-terminal Telopeptide of Collagen (CTx) Levels Week 12	0.092 ng/ml Interval 0.04 to 0.145	0.297 ng/ml Interval 0.24 to 0.353
Baseline-Adjusted Means for C-terminal Telopeptide of Collagen (CTx) Levels Week 24	0.122 ng/ml Interval 0.074 to 0.171	0.331 ng/ml Interval 0.276 to 0.384
Baseline-Adjusted Means for C-terminal Telopeptide of Collagen (CTx) Levels Week 48	0.122 ng/ml Interval 0.077 to 0.168	0.264 ng/ml Interval 0.215 to 0.313
Baseline-Adjusted Means for C-terminal Telopeptide of Collagen (CTx) Levels Week 72	0.138 ng/ml Interval 0.088 to 0.189	0.242 ng/ml Interval 0.188 to 0.296
Baseline-Adjusted Means for C-terminal Telopeptide of Collagen (CTx) Levels Week 96	0.126 ng/ml Interval 0.042 to 0.209	0.321 ng/ml Interval 0.238 to 0.404
Baseline-Adjusted Means for C-terminal Telopeptide of Collagen (CTx) Levels Week 120	0.137 ng/ml Interval 0.088 to 0.187	0.201 ng/ml Interval 0.151 to 0.25
Baseline-Adjusted Means for C-terminal Telopeptide of Collagen (CTx) Levels Week 144	0.148 ng/ml Interval 0.096 to 0.2	0.200 ng/ml Interval 0.147 to 0.254

SECONDARY outcome

Timeframe: Baseline, Week 144

Population: Participants with osteocalcin measurements at Week 144 are included in this analysis.

Osteocalcin was evaluated to examine the inhibitory effect of single dose zoledronic acid on HAART associated changes in markers of bone turnover. Osteocalcin is released from bone during resorption and higher levels in the circulatory system indicate increased bone turnover. HIV-infected individuals are expected to have increased bone resorption. The baseline-adjusted osteocalcin mean is defined as the predicted response value obtained by fitting the regression equation for each treatment arm at the mean baseline value for the 2 treatment arms. The adjusted means were estimated using analysis of covariance at the Week 144 clinic visit. Baseline-adjusted means of osteocalcin at week 144 are presented.

Outcome measures

Outcome measures
Measure	Zoledronic Acid n=21 Participants Subjects in this arm will receive 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel. Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes. b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.	Placebo n=20 Participants Subjects in the placebo arm will receive placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered iv over 15-30 minutes under the supervision of study personnel. Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes. b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.
Baseline-Adjusted Means of Osteocalcin	9.176 ng/ml Interval 4.557 to 13.796	13.597 ng/ml Interval 8.862 to 18.332

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 144

Population: This analysis includes participants who had a DXA scan performed at baseline and at least one additional study visit.

Development of osteoporosis was assessed by examining bone mineral density (BMD) by DXA scan. Baseline-adjusted means of DXA scan Z-scores are presented for the lumbar spine (L1-L4), left hip, and femur neck. The baseline-adjusted BMD mean is defined as the predicted response value obtained by fitting the regression equation for each treatment arm at the mean baseline value for the 2 treatment arms. The adjusted means were estimated using analysis of covariance at the Week 144 clinic visit. Bone density Z-scores tell how close to the average that a person is (adjusted for age, race, and gender). A Z-score of 0 means the value matches that of the average person. Z-score values below 0 indicate lower than average bone density while values above 0 indicate higher bone density than the average person.

Outcome measures

Outcome measures
Measure	Zoledronic Acid n=29 Participants Subjects in this arm will receive 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel. Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes. b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.	Placebo n=20 Participants Subjects in the placebo arm will receive placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered iv over 15-30 minutes under the supervision of study personnel. Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes. b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.
Baseline-Adjusted Means of Dual-energy X-ray Absorptiometry (DXA) Lumbar Spine	-0.177 Z score Interval -0.371 to 0.016	-0.836 Z score Interval -1.062 to -0.609
Baseline-Adjusted Means of Dual-energy X-ray Absorptiometry (DXA) Hip	-0.860 Z score Interval -0.992 to -0.728	-1.092 Z score Interval -1.246 to -0.938
Baseline-Adjusted Means of Dual-energy X-ray Absorptiometry (DXA) Femoral Neck	-0.665 Z score Interval -0.833 to -0.498	-0.817 Z score Interval -1.012 to -0.622

POST_HOC outcome

Timeframe: Week 144

Population: All participants are included in this analysis, using all available measurements of viral load.

The percentage of participants achieving viral load suppression by study week 144. Virologic suppression was defined as HIV RNA polymerase chain reaction (PCR) (viral loads) less than 50 copies per mL.

Outcome measures

Outcome measures
Measure	Zoledronic Acid n=34 Participants Subjects in this arm will receive 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel. Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes. b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.	Placebo n=29 Participants Subjects in the placebo arm will receive placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered iv over 15-30 minutes under the supervision of study personnel. Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes. b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.
Percentage of Participants With Virological Suppression by Week 144	91 percentage of participants	100 percentage of participants

POST_HOC outcome

Timeframe: Baseline, Week 144

Population: This analysis includes participants with a CD4 count measurement at the time points indicated.

Immunologic response measured by CD4 T cell count by treatment arm and weeks on study.

Outcome measures

Outcome measures
Measure	Zoledronic Acid n=34 Participants Subjects in this arm will receive 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel. Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes. b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.	Placebo n=29 Participants Subjects in the placebo arm will receive placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered iv over 15-30 minutes under the supervision of study personnel. Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes. b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.
CD4 T Cell Count Baseline	102 cells/uL Standard Deviation 69	155 cells/uL Standard Deviation 145
CD4 T Cell Count Week 144	347 cells/uL Standard Deviation 27	439 cells/uL Standard Deviation 52

Adverse Events

Zoledronic Acid

Serious events: 7 serious events

Other events: 34 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zoledronic Acid n=34 participants at risk 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 n=29 participants at risk 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.
Endocrine disorders Hospitalization due to pancreatitis	2.9% 1/34 • Number of events 1 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.	0.00% 0/29 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
General disorders Hospitalization due to abdominal pain	2.9% 1/34 • Number of events 1 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.	0.00% 0/29 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Hospitalization due to community acquired pneumonia	2.9% 1/34 • Number of events 1 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.	10.3% 3/29 • Number of events 3 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
Infections and infestations Hospitalization due to neurosyphilis	2.9% 1/34 • Number of events 1 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.	0.00% 0/29 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
General disorders Hospitalization	2.9% 1/34 • Number of events 1 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.	0.00% 0/29 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
Gastrointestinal disorders Hospitalization due to gastro esphageal reflux disease	2.9% 1/34 • Number of events 1 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.	0.00% 0/29 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
Psychiatric disorders Psychiatric hospitalization	0.00% 0/34 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.	3.4% 1/29 • Number of events 1 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Hospitalization due to brochitis and otitis externa	2.9% 1/34 • Number of events 1 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.	0.00% 0/29 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
Endocrine disorders Hospitalization related to Graves' Disease	0.00% 0/34 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.	3.4% 1/29 • Number of events 3 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
Vascular disorders Hospitalization due to sub-acute cerebrovascular accident	0.00% 0/34 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.	3.4% 1/29 • Number of events 1 • Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist. The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.

Other adverse events

Additional Information

Igho Ofotokun, MD, MSc

Emory University

Phone: 404-616-0659

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place