Status:
COMPLETED
An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL in HIV+ Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Metabolism, Lipids
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
1. In order to obtain further insight as to how NVP affects HDL metabolism, the in vivo kinetics of the HDL apolipoprotein, Apo A-1, before and 6 weeks after initiation of NVP containing treatment wer...
Eligibility Criteria
Inclusion
- Patients will be included when they meet the following criteria:
- 18 years of age or older.
- Ability and willingness to provide signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
- Patients on stable therapy with Trizivir only (or its equivalent component drugs), for at least 6 months prior to screening.
- Patients with plasma HIV-1-RNA \<=50 copies/mL documented on at least two occasions within 6 months prior to enrollment.
- Documentation of plasma HIV-1 RNA of \<=50 copies/mL for \>=6 months while on Trizivir without other antiretroviral agent. Documentation will include dates and results of all viral load testing from the previous six months.
- Ability and willingness to complete the study.
Exclusion
- Patients will not be included when they meet one or more of the following criteria:
- Previous exposure to NNRTI drugs.
- Documented diabetes mellitus.
- Documented hypertension (systolic \>155 mmHg and/or diastolic \>95 mmHg).
- Fasting hypertriglyceridemia (\>5.6 mmol/L or 500 mg/dl).
- Use of lipid-lowering medication during the 90 days prior to study enrollment.
- Chronic active hepatitis B and/or C infection by history.
- Anemia (Hb \<7.0 mmol/l or 11 g/dl hematocrit \<32%).
- Active opportunistic infection or neoplasm within 3 months prior to screening visit with the exception of cutaneous Kaposi's sarcoma without evidence of progressive disease.
- Any history of cardiovascular disease (infarction, heart failure, peripheral vascular disease, cerebrovascular disease).
- Hepatic, renal or thyroid abnormalities, as determined significant by the Principal Investigator.
- Pregnancy or lactation.
- Active anticoagulation therapy (coumarin derivates, heparin).
- History of HIV-2 infection.
- Female patients with CD4 counts \>250 cells/mm3.
- Male patients with CD4 counts \>400 cells/mm3. Others which can not be listed here.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00144261
Start Date
November 1 2003
Last Update
January 31 2025
Active Locations (3)
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1
1100.1426.01 Academic Medical Centre
Amsterdam, Netherlands
2
1100.1426.02 Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
3
1100.1426.44001 Boehringer Ingelheim Investigational Site
London, United Kingdom