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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144261
• Other study ID #: 1100.1426
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2005
• Last updated: December 27, 2017
• Start date: November 2003

Study information

• Verified date: December 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

10. Hepatic, renal or thyroid abnormalities, as determined significant by the Principal Investigator.

11. Pregnancy or lactation.

12. Active anticoagulation therapy (coumarin derivates, heparin).

13. History of HIV-2 infection.

14. Female patients with CD4 counts >250 cells/mm3.

15. Male patients with CD4 counts >400 cells/mm3. Others which can not be listed here.

Related Conditions & MeSH terms

• HIV Infections
• Metabolism, Lipids

Intervention

Drug:
• nevirapine

Locations

Country	Name	City	State
Netherlands	1100.1426.01 Academic Medical Centre	Amsterdam
Netherlands	1100.1426.02 Onze Lieve Vrouwe Gasthuis	Amsterdam
United Kingdom	1100.1426.44001 Boehringer Ingelheim Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change of fractional synthetic rate (FSR) of Apo A-1		after 6 weeks of treatment
Primary	Percentage change of flow mediated dilatation (FMD)		after 6 and 24 weeks of treatment
Secondary	Percentage change in the proteins involved in HDL metabolism		after 6 and 24 weeks of treatment
Secondary	The percentage change in plasma levels of lipoproteins in the fasting lipid panel (TC, LDL, HDL, TG) from Week 0 (baseline) to 6 and 24 weeks of treatment with NVP-based antiretroviral therapy		from week 0 to 6, and 24 weeks of treatment
Secondary	The percentage change in activity (and/or mass) of the constituents of the lipid enzymes panel from Week 0 to 24 weeks of NVP-based antiretroviral therapy		from week 0 to 24 weeks of treatment

External Links

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