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| ID | Type | Description | Link |
|---|---|---|---|
| CTN 169 |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| CIHR Canadian HIV Trials Network | NETWORK |
The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed.
Participants will be randomly assigned to one of four groups:
The study plans to involve eighty participants from Canada and Argentina for a treatment period of 16 weeks and a follow-up visit at week 24.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| d4T | Drug | See Detailed Description. | ||
| Abacavir | Drug | See Detailed Description. | ||
| Riboflavin and Thiamine (Supplementation) | Drug | See Detailed Description. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients per arm with random venous lactic acid (RVLA) below or equal to 2.1 mmol/L* at 16 weeks. (* Confirmed by a second determination 7-14 days later.) | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of decline of RVLA levels | ||
| Absolute level of change of RVLA levels using baseline values as a covariant | ||
| Proportion of patients improving/normalizing exercise testing mitochondrial dysfunction pattern |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julio Montaner, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada | ||
| Positive Care Clinic |
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| ID | Term |
|---|---|
| D000140 | Acidosis, Lactic |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018119 | Stavudine |
| C106538 | abacavir |
| D012256 | Riboflavin |
| D013831 | Thiamine |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Time to event: time to normalize venous lactic acid |
| Time to event: premature therapy discontinuation, viral load rebound, and progression to a new AIDS defining illness or death |
| Proportion of patients with at least three consecutive HIV-1 RNA determinations equal to or below 50 copies/mL during the 16 week follow-up period on an intention to treat basis | 16 weeks |
| Change in absolute CD4 from baseline |
| Absolute CD4/CD8 counts |
| Incidence of grade III and greater adverse drug effects |
| Metabolic laboratory assessments (anion gap, lipid and hepatic profile, and hematology) |
| Toronto |
| Ontario |
| Canada |
| D006571 |
| Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |