HIV
Conditions
Keywords
treatment experienced
Brief summary
Study subjects receiving the antiretroviral drugs Combivir or trizivir, will be randomized to switch to Truvada-containing highly active antiretroviral therapy (HAART) or to continue on Combivir or on trizivir. Measurements will be performed at baseline and after 6 months after randomization to either continuing on trizivir or combivir, or to switching to Truvada. Measurements include maximal or peak oxygen consumption, lactate production and clearance, subcutaneous adipose tissue and limb fat contents, insulin resistance, liver and muscle fat contents, and plasma free fatty acid concentrations. The hypothesis underlying this study is that chronic therapy with thymidine analogue nucleoside reverse transcriptase inhibitors (NRTIs), including zidovudine (AZT), leads to clinically detectable mitochondrial dysfunction in several organ systems.
Detailed description
None different from the summary description above.
Interventions
DRUGTruvada
Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months
DRUGCombivir
Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months
DRUGTrizivir
Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)
Sponsors
Gilead Sciences
St. Luke's-Roosevelt Hospital Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* infection with human immunodeficiency virus (HIV) with undetectable viral load * on Combivir or trizivir * able to exercise and sign consent
Exclusion criteria
* other active illness * contraindication to magnetic resonance imaging (MRI) scanning or maximal exercise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Oxygen Uptake. | baseline and 6 months | change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from clinics.
Pre-assignment details
Subjects had to take combivir or trizivir for at least 6 months prior to enrollment
Participants by arm
| Arm | Count |
|---|---|
| Truvada switch from Combivir to Truvada | 10 |
| Combivir, Trizivir. continue on Combivir, trizivir. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Truvada | Combivir, Trizivir. | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age Continuous | 52 years STANDARD_DEVIATION 6 | 53 years STANDARD_DEVIATION 4 | 53 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change in Peak Oxygen Uptake.
change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups.
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Truvada 200/300 mg, Daily, by Mouth. | Change in Peak Oxygen Uptake. | 2.2 ml/Kg/min | Standard Deviation 8.5 |
| Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily. | Change in Peak Oxygen Uptake. | 2.8 ml/Kg/min | Standard Deviation 3.3 |
Comparison: Paired t-tests for inter-group differences between baseline and end-of-study measurements.Regression analysis, physiological correlates of statistically significant between-group changes.~P\<0.05 chosen for statistical significancep-value: <0.0595% CI: [-6.3, 11.3]t-test, 2 sided