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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment |
| Condition: |
HIV-1 |
| Interventions: |
Drug: Truvada Drug: AZT/3TC |
Baseline Characteristics
| Description | |
|---|---|
| TVD | Truvada + NNRTI or PI. |
| AZT/3TC | AZT/3TC + NNRTI or PI. |
| TVD | AZT/3TC | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
39 | 41 | 80 |
|
Age [units: years] Mean ± Standard Deviation |
44 ± 10.6 | 44 ± 7.4 | 44 ± 9.0 |
|
Gender [units: participants] |
|||
| Female | 11 | 4 | 15 |
| Male | 28 | 37 | 65 |
|
Race, Customized [units: Participants] |
|||
| White | 36 | 38 | 74 |
| Black, of African heritage | 1 | 2 | 3 |
| Asian | 1 | 0 | 1 |
| Other (South American) | 1 | 1 | 2 |
|
Region of Enrollment [units: participants] |
|||
| Spain | 39 | 41 | 80 |
|
HIV-1 RNA Level [units: Participants] |
|||
| < 50 copies/mL | 38 | 39 | 77 |
| 50 to < 400 copies/mL | 1 | 2 | 3 |
|
Cluster determinant 4 (CD4) cell count [units: cells/mm^3] Median ( Inter-Quartile Range ) |
655.0 ( 505.0 to 789.0 ) |
504.0 ( 363.0 to 756.0 ) |
600.5 ( 420.0 to 760.5 ) |
|
Total limb fat[1] [units: g] Median ( Full Range ) |
3565 ( 511 to 15932 ) |
3589 ( 903 to 28155 ) |
3589 ( 511 to 28155 ) |
|
Years on AZT/3TC [units: Years] Median ( Inter-Quartile Range ) |
5.8 ( 4.2 to 7.2 ) |
6.2 ( 4.7 to 7.2 ) |
5.9 ( 4.6 to 7.2 ) |
| [1] | Measured using DEXA. Total limb fat is the sum of the left arm, right arm, left leg, and right leg. |
|---|
Outcome Measures
| 1. Primary: | Change From Baseline in Limb Fat at Week 48 [ Week 48 ] |
| 2. Secondary: | Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa) [ 48 weeks ] |
| 3. Secondary: | Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes) [ 48 weeks ] |
| 4. Secondary: | Change From Baseline in Lactate Concentration [ 48 weeks ] |
| 5. Secondary: | Percentage of Days for Which Participants Were Compliant With Study Drug [ 72 weeks ] |
| 6. Secondary: | Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL [ 48 weeks ] |
| 7. Secondary: | Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL [ 48 weeks ] |
| 8. Secondary: | Percentage of Participants With Virologic Failure [ 48 weeks ] |
| 9. Secondary: | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count [ 48 weeks ] |
| 10. Secondary: | Change From Baseline in Fasting Serum Triglycerides [ 48 weeks ] |
| 11. Secondary: | Change From Baseline in Fasting Total Cholesterol [ 48 weeks ] |
| 12. Secondary: | Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL) [ 48 weeks ] |
| 13. Secondary: | Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL) [ 48 weeks ] |
| 14. Secondary: | Change From Baseline in Hemoglobin [ 48 weeks ] |
| 15. Secondary: | Change From Baseline in Hematocrit [ 48 weeks ] |
| 16. Secondary: | Change From Baseline in Waist Circumference/Hip Circumference Ratio [ 48 weeks ] |
| 17. Secondary: | Percentage of Participants With Any Adverse Event [ 72 weeks ] |
| 18. Secondary: | Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events. [ 48 weeks ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Gilead Sciences ( Pedro Ferrer ) |
| Study ID Numbers: | GS-ES-164-0154 |
| Study First Received: | May 9, 2006 |
| Results First Received: | March 30, 2009 |
| Last Updated: | March 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00324649 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicines |