Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
None different from the summary description above.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Truvada | Experimental | Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months |
|
| Combivir or Trizivir | Active Comparator | Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months or Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Truvada | Drug | Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Donald P Kotler, MD | St Luke's Roosevelt Hospital New York City | Principal Investigator |
| Gabriel Ionescu, MD | SLRHC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's-Roosevelt Hospital Center | New York | New York | 10025 | United States |
Subjects had to take combivir or trizivir for at least 6 months prior to enrollment
Subjects were recruited from clinics.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Truvada 200/300 mg, Daily, by Mouth. | The study subjects will be randomly assigned to switch from Combivir or from trizivir to open-label Truvada. |
| FG001 | Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily. | The study subjects will be randomly assigned to continue on Combivir or trizivir.This will serve as comparator group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Truvada | switch from Combivir to Truvada |
| BG001 | Combivir, Trizivir. | continue on Combivir, trizivir. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Sep 2011 | Mean | Standard Deviation | ml/Kg/min | baseline and 6 months |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Truvada | switch from Combivir to Truvada |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Donald Phillip Kotler | St Luke's Roosevelt Hospital New York | 212 523 3670 | dkotler@chpnet.org |
Not provided
| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| C109078 | lamivudine, zidovudine drug combination |
| D015215 | Zidovudine |
| D019259 | Lamivudine |
| C418262 | abacavir, lamivudine, and zidovudine drug combination |
| C106538 | abacavir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Combivir | Drug | Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months |
|
|
| Trizivir | Drug | Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine) |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
continue on Combivir 150/300 mg, or trizivir 300/150/300 mg daily.
|
|
|
| 0 |
| 10 |
| 0 |
| 0 |
| EG001 | Combivir, Trizivir. | continue on Combivir, trizivir. | 0 | 10 | 0 | 0 |
Not provided
Not provided
| D003562 |
| Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013936 | Thymidine |
| D015224 | Dideoxynucleosides |
| D016047 | Zalcitabine |