Phase 4
N=92
TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00323492 ↗Enrolled (actual)
92
Serious AEs
10.4%
Results posted
Dec 2009
Primary outcome: Primary: Change From Baseline to Week 12 in Fasting Triglycerides — -0.5; -0.1 mmol/L — p=0.034
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Truvada (Drug); Current HAART regimen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in Fasting Triglycerides |
-0.5; -0.1 | 0.034 sig |
| PRIMARY Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO) |
-0.4; -0.1 | 0.031 sig |
| SECONDARY Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO) |
-0.1; 0.0 | 0.009 sig |
| SECONDARY Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO) |
-0.8; -0.1 | < 0.001 sig |
| SECONDARY Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO |
-0.5; -0.1 | 0.51 |
| SECONDARY Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO |
0.0; 0.0 | 0.79 |
| SECONDARY Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP) |
0.4; 0.7 | 0.86 |
| SECONDARY Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12 |
0; 0 | — |
| SECONDARY Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count |
17.5; 16.0 | 0.65 |
| SECONDARY Change From Baseline to Week 48 in CD4 Cell Count |
35.0; 40.0 | 0.11 |
| SECONDARY Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12 |
96; 98 | 1.00 |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12 |
0; 0 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 |
80; 80 | — |
Summary
This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing highly active antiretroviral therapy (HAART) regimen were switched to Truvada® (a fixed dose combination tablet of emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg [FTC/TDF]). Subjects continued their nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) at the same dose.
Eligibility Criteria
Inclusion Criteria
- Patients displaying abnormal fasted triglycerides (> 2 g/L [2.26 mmol/L] and less than or equal to 10 g/L [11.29 mmol/L]) and/or fasted low density lipoprotein cholesterol (LDL-CHO; > 1.6 g/L [4.15 mmol/L])
- Patients on stable HAART with 2 NRTIs + 1 NNRTI or 1 PI for at least 3 months prior to screening, and with plasma viral load < 400 copies/mL for at least 6 months prior to screening
Data sourced from ClinicalTrials.gov (NCT00323492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.