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Efficacy and pharmacokinetics of a switch from a regimen consisting of emtricitabine, nevirapine and tenofovir to rilpivirine, emtricitabine and tenofovir in virologically suppressed HIV-1 infected patients.

Efficacy and pharmacokinetics of a switch from a regimen consisting of emtricitabine, nevirapine and tenofovir to rilpivirine, emtricitabine and tenofovir in virologically suppressed HIV-1 infected patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26054
Enrollment
50
Registered
2012-03-26
Start date
2012-07-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Interventions

Switch from nevirapine to Eviplera® (=rilpivirine, emtricitabine, tenofovir) in patients treated with nevirapine, tenofovir and emtricitabine.

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Able to take medication with a 500 kcal meal; 2. Treated with NVP, FTC, TDF for at least the last 9 months; 3. No history of HIV virologic failure; 4. The last 2 measured HIV-RNA levels in plasma were <50 copies/ml; 5. &#8805;6 months between the first and last plasma with <50 copies/ HIV RNA/ml.

Exclusion criteria

Exclusion criteria: 1. Use of proton pump inhibitors; 2. Use of H2-antagonists.

Design outcomes

Primary

MeasureTime frame
Number of subjects with HIV-1 RNA <50 c/mL at Week 12 (ITT population, snapshot analysis).—

Secondary

MeasureTime frame
1. Cmin RPV levels in patients that switch from NVP to RPV at 1, 2, 4, 6, 8, 12 and 24 weeks in comparison with Cmin observed in fase III RPV trial; 2. Number of subjects with HIV-1 RNA <50 c/mL at Week 24 and 48 post-switch (ITT population, snapshot analysis).—

Contacts

Public ContactBart Rijnders

Postbus 2040

b.rijnders@erasmusmc.nl+31 (0)10 7033510

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)