Trial Outcomes & Findings for The Effects of Ageing on the 'Pharmacokinetic and Clinical Observations in People Over Fifty' (NCT NCT01737047)
NCT ID: NCT01737047
Last Updated: 2025-09-18
Results Overview
The number of patients reporting aches and pains in the 3 arms were used to analyse the incidence and outcomes of co-morbidities in older-HIV-positive people and their relationship with demographic/clinical factors.Comparison of three groups HIV+ve \>50, HIV+\<50 and HIV-ve \>50.
Recruitment status
COMPLETED
Target enrollment
1377 participants
Primary outcome timeframe
after 1 year
Results posted on
2025-09-18
Participant Flow
Participant milestones
| Measure |
HIV Positive Over 50 Years of Age
All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
Blood sample collections for the determination of the plasma concentrations of tenofovir and the third agent (i.e. a non-nucleoside reverse transcriptase, protease, entry or integrase inhibitor) in the patient's regimen will be drawn
|
HIV Positive Under the Age of 50
All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
Blood sample collections for the determination of the plasma concentrations of tenofovir and the third agent (i.e. a non-nucleoside reverse transcriptase, protease, entry or integrase inhibitor) in the patient's regimen will be drawn
|
HIV Negative Over the Age of 50
All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
699
|
374
|
304
|
|
Overall Study
COMPLETED
|
672
|
363
|
299
|
|
Overall Study
NOT COMPLETED
|
27
|
11
|
5
|
Reasons for withdrawal
| Measure |
HIV Positive Over 50 Years of Age
All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
Blood sample collections for the determination of the plasma concentrations of tenofovir and the third agent (i.e. a non-nucleoside reverse transcriptase, protease, entry or integrase inhibitor) in the patient's regimen will be drawn
|
HIV Positive Under the Age of 50
All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
Blood sample collections for the determination of the plasma concentrations of tenofovir and the third agent (i.e. a non-nucleoside reverse transcriptase, protease, entry or integrase inhibitor) in the patient's regimen will be drawn
|
HIV Negative Over the Age of 50
All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
|
|---|---|---|---|
|
Overall Study
Death
|
10
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
17
|
11
|
4
|
Baseline Characteristics
The Effects of Ageing on the 'Pharmacokinetic and Clinical Observations in People Over Fifty'
Baseline characteristics by cohort
| Measure |
HIV Positive Over 50 Years of Age
n=699 Participants
All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
Blood sample collections for the determination of the plasma concentrations of tenofovir and the third agent (i.e. a non-nucleoside reverse transcriptase, protease, entry or integrase inhibitor) in the patient's regimen will be drawn
|
HIV Positive Under the Age of 50
n=374 Participants
All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
Blood sample collections for the determination of the plasma concentrations of tenofovir and the third agent (i.e. a non-nucleoside reverse transcriptase, protease, entry or integrase inhibitor) in the patient's regimen will be drawn
|
HIV Negative Over the Age of 50
n=304 Participants
All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
|
Total
n=1377 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
43 years
n=7 Participants
|
58 years
n=5 Participants
|
56 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
268 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
612 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
1109 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
96 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
603 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
1175 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: after 1 yearThe number of patients reporting aches and pains in the 3 arms were used to analyse the incidence and outcomes of co-morbidities in older-HIV-positive people and their relationship with demographic/clinical factors.Comparison of three groups HIV+ve \>50, HIV+\<50 and HIV-ve \>50.
Outcome measures
| Measure |
HIV Positive Over 50 Years of Age (Median Age 57)
n=699 Participants
All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
Blood sample collections for the determination of the plasma concentrations of tenofovir and the third agent (i.e. a non-nucleoside reverse transcriptase, protease, entry or integrase inhibitor) in the patient's regimen will be drawn
|
HIV Positive Under the Age of 50 (Median Age 43)
n=374 Participants
All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
Blood sample collections for the determination of the plasma concentrations of tenofovir and the third agent (i.e. a non-nucleoside reverse transcriptase, protease, entry or integrase inhibitor) in the patient's regimen will be drawn
|
HIV Negative Over the Age of 50 (Median Age 58)
n=304 Participants
All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
|
|---|---|---|---|
|
The Prevalence of Reported Aches and Pains in the Last Month Across the 3 Age Groups
|
473 participants
|
224 participants
|
188 participants
|
Adverse Events
HIV Positive Under the Age of 50
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Negative Over the Age of 50
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Positive Over 50 Years of Age
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place