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COMPLETEDPHASE4

An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL in HIV+ Subjects

An Open-label, Non-randomized, Single-arm Study, to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma High Density Lipoproteins Concentration in HIV+ Subjects Treated With VIRAMUNE® Tablets

NCT00144261•Boehringer Ingelheim

View on ClinicalTrials.gov

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 were evaluated. In addition, the activity of the key enzymes related to HDL metabolism were assessed. \[ Designated as safety issue: No \] 2. In order to determine the relevance of the HDL increase in decreasing cardiovascular risk in HIV-positive subjects we evaluated endothelial function (FMD) as a surrogate marker for cardiovascular disease in patients. \[ Designated as safety issue: No \]

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients will be included when they meet the following criteria:
•1. 18 years of age or older.
•2. Ability and willingness to provide signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
•3. Patients on stable therapy with Trizivir only (or its equivalent component drugs), for at least 6 months prior to screening.
•4. Patients with plasma HIV-1-RNA \<=50 copies/mL documented on at least two occasions within 6 months prior to enrollment.
•5. 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.
•6. Ability and willingness to complete the study.

Exclusion Criteria

•Patients will not be included when they meet one or more of the following criteria:
•1. Previous exposure to NNRTI drugs.
•2. Documented diabetes mellitus.
•3. Documented hypertension (systolic \>155 mmHg and/or diastolic \>95 mmHg).
•4. Fasting hypertriglyceridemia (\>5.6 mmol/L or 500 mg/dl).
•5. Use of lipid-lowering medication during the 90 days prior to study enrollment.
•6. Chronic active hepatitis B and/or C infection by history.
•7. Anemia (Hb \<7.0 mmol/l or 11 g/dl hematocrit \<32%).
•8. 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.
•9. Any history of cardiovascular disease (infarction, heart failure, peripheral vascular disease, cerebrovascular disease).
+6 more criteria

Locations (3)

1100.1426.01 Academic Medical Centre

Amsterdam, Netherlands

1100.1426.02 Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

1100.1426.44001 Boehringer Ingelheim Investigational Site

London, United Kingdom

Key Dates

Start Date

November 1, 2003

Primary Completion Date

December 1, 2006

Last Updated

January 31, 2025

Enrollment

ACTUAL participants

Conditions

HIV InfectionsMetabolism, Lipids

Interventions

nevirapine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL in HIV+ Subjects

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

Skeletal Muscle Energetics and Fatiguability in Older Individuals

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