Trial Outcomes & Findings for Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications (NCT NCT00433992)
NCT ID: NCT00433992
Last Updated: 2017-09-05
Results Overview
mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.
Recruitment status
COMPLETED
Target enrollment
56 participants
Primary outcome timeframe
Entry, Week 96
Results posted on
2017-09-05
Participant Flow
Participant milestones
| Measure |
ABC/3TC
HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
|
TDF/FTC
HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications
Baseline characteristics by cohort
| Measure |
ABC/3TC
n=28 Participants
HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
|
TDF/FTC
n=28 Participants
HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Entry, Week 96mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.
Outcome measures
| Measure |
ABC/3TC+EFV
n=15 Participants
HIV-infected subjects taking abacavir-lamivudine (ABC/3TC) with Efavirenz at baseline
|
TDF/FTC+EFV
n=13 Participants
HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with Efavirenz at baseline
|
ATV/r +TDF/FTC
n=15 Participants
HIV infected subjects taking atazanavir-ritonavir with tenofovir DF-emtricitabine at baseline
|
ATV/r +ABC/3TC
n=13 Participants
HIV-infected subjects taking atazanavir-ritonavir with abacavir-lamivudine at baseline
|
|---|---|---|---|---|
|
Change in Mitochondrial Activity
|
1250 copies/cell
Interval 998.0 to 1886.0
|
1312 copies/cell
Interval 920.0 to 1609.0
|
1150 copies/cell
Interval 721.0 to 1423.0
|
1125 copies/cell
Interval 1049.0 to 1588.0
|
SECONDARY outcome
Timeframe: Entry, Week 48Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry
Outcome measures
| Measure |
ABC/3TC+EFV
n=19 Participants
HIV-infected subjects taking abacavir-lamivudine (ABC/3TC) with Efavirenz at baseline
|
TDF/FTC+EFV
n=20 Participants
HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with Efavirenz at baseline
|
ATV/r +TDF/FTC
HIV infected subjects taking atazanavir-ritonavir with tenofovir DF-emtricitabine at baseline
|
ATV/r +ABC/3TC
HIV-infected subjects taking atazanavir-ritonavir with abacavir-lamivudine at baseline
|
|---|---|---|---|---|
|
Change in Fat Apoptosis
|
906 g
Interval -349.0 to 1900.0
|
1479 g
Interval 353.0 to 3032.0
|
—
|
—
|
Adverse Events
ABC/3TC
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
TDF/FTC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ABC/3TC
n=28 participants at risk
HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
|
TDF/FTC
n=28 participants at risk
HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
1/28 • Number of events 1 • the adverse event data was collected over the duration of the study of 96 weeks
|
0.00%
0/28 • the adverse event data was collected over the duration of the study of 96 weeks
|
|
Psychiatric disorders
Depression
|
3.6%
1/28 • Number of events 1 • the adverse event data was collected over the duration of the study of 96 weeks
|
0.00%
0/28 • the adverse event data was collected over the duration of the study of 96 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place