N/A
N=334
Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00543803 ↗Enrolled (actual)
334
Serious AEs
5.7%
Results posted
Jan 2011
Primary outcome: Primary: Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment — 1.0 IU/L
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment |
1.0 | — |
| PRIMARY Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment |
4.0 | — |
| PRIMARY Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment |
23.0 | — |
| PRIMARY Summary of Change From Baseline in Creatinine to Last Value on Treatment |
0.0 | — |
| PRIMARY Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment |
12.0 | — |
| PRIMARY Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment |
6.0 | — |
| PRIMARY Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment |
5.0 | — |
| PRIMARY Summary of Change From Baseline in Triglycerides to Last Value on Treatment |
-7.0 | — |
| PRIMARY Summary of Change From Baseline in Glucose to Last Value on Treatment |
0.0 | — |
| SECONDARY Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment |
-2.3 | — |
| SECONDARY Summary of Change From Baseline in CD4+ Count to Last Value on Treatment |
141 | — |
| SECONDARY Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator |
57 | — |
| SECONDARY Investigator's Global Clinical Assessment of Patient General Health Status |
193; 273; 127; 49; 10; 4 | — |
Summary
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and Truvada (tenofovir and emtricitabine).
Eligibility Criteria
Inclusion criteria
- male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with PIs has failed, or who have to switch their previous treatment from protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRT)I due to side effects or intolerability after achieving suppression of viral load below the limit of detection.
- Viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.
- Truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.
Exclusion criteria
- Age 5 upper limit normal (ULN) until baseline ASAT/ALAT are stabilised 5 ULN during Viramune (nevirapine) therapy and had recurrence of liver function abnormalities upon readministration of Viramune (nevirapine)
- Herbal preparations containing St Johns wort (Hypericum perforatum) must not be used while taking Viramune (nevirapine) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine
- The available pharmacokinetic data suggest that the concomitant use of rifampicin and Viramune (nevirapine) is not recommended.
Data sourced from ClinicalTrials.gov (NCT00543803). 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.