Trial Outcomes & Findings for Angiotensin Receptors and Age Related Mitochondrial Decline in HIV Patients (NCT NCT02606279)
NCT ID: NCT02606279
Last Updated: 2018-08-28
Results Overview
Measured by time to finish 400 meter walk
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
3, 6, and 9 months post-enrollment
Results posted on
2018-08-28
Participant Flow
Participant milestones
| Measure |
Placebo Control
20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.
Placebo
|
Valsartan
20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.
valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo Control
20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.
Placebo
|
Valsartan
20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.
valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Angiotensin Receptors and Age Related Mitochondrial Decline in HIV Patients
Baseline characteristics by cohort
| Measure |
Placebo Control
20 HIV-infected participants will be randomized into a blinded arm where they will receive 24 weeks of placebo therapy. During this time, they will undergo the same study procedures as the intervention arm.
Placebo
|
Valsartan
n=1 Participants
20 HIV-infected participants will be randomized into a blinded arm where they receive 24 weeks of valsartan therapy. For those subjects randomized to the valsartan group, they will receive valsartan 40 mg by mouth daily for 2 weeks, then increase to 80 mg by mouth daily for the remaining 22 weeks. During this time, they will undergo the same study procedures as the placebo arm.
valsartan: Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Prefers not to identify
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3, 6, and 9 months post-enrollmentPopulation: Participant did not complete visits, data not collected.
Measured by time to finish 400 meter walk
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3, 6, and 9 months post-enrollmentPopulation: Participant did not complete visits, data not collected.
Measured by dynamometer measurement of grip strength
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3, 6, and 9 months post-enrollmentPopulation: Participant did not complete visits, data not collected.
Measured by using qPCR and western blot. (Units are arbitrary units)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3, 6, and 9 months post-enrollmentPopulation: Participant did not complete visits, data not collected.
Evaluated by measurements of grip strength, walking speed and questionnaires
Outcome measures
Outcome data not reported
Adverse Events
Placebo Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Valsartan
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
Katherine Schafer, Assistant Professor Internal Medicine
Wake Forest University Health Sciences
Phone: 13367166342
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place