Phase 4
Completed N=60
FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment
Source: ClinicalTrials.gov NCT00414635 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Jan 2011
Primary outcomePrimary: Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml) — 100; 86 Percentage of Participants
Summary
For people with HIV who are currently taking specific medications (including Sustiva (efavirenz)) and have no detectable viral load, this study tracks how patients do if they take their medications for five days of the week compared with seven days of the week.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml) |
100; 86 | — |
| SECONDARY Mean CD4+ T-cell Count Increases From Baseline to Week 24. |
-1.9; -9.3 | — |
| SECONDARY Quality of Life |
9.5 | — |
| SECONDARY Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks |
8; 10 | — |
| SECONDARY Trough Blood Levels of Efavirenz in Both Arms |
48; 90; 37; 1; 15; 9 | — |
| SECONDARY Self-reported Adherence Summary in Both Arms |
10; 17; 15; 7; 8; 11 | — |
| SECONDARY Deviation From FOTO Schedule by One Extra Dose |
10; 4; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- CD4 count > or = 200
- Viral load < 50
- Treatment with a regimen containing efavirenz and tenofovir and lamivudine or emtricitabine for at least 90 days prior to screening
Exclusion Criteria
- Detectable HIV RNA on an ultrasensitive assay within the 90 days preceding screening
- Prior evidence of intermediate or high level resistance to efavirenz, tenofovir or cytidine analogues
- Hepatitis B infection
Data sourced from ClinicalTrials.gov (NCT00414635). 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. Informational only — not medical advice.