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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144261
First received: September 2, 2005
Last updated: November 4, 2013
Last verified: November 2013

September 2, 2005
November 4, 2013
November 2003
December 2006   (final data collection date for primary outcome measure)
  • Percentage change of fractional synthetic rate (FSR) of Apo A-1 [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
  • Percentage change of flow mediated dilatation (FMD) [ Time Frame: after 6 and 24 weeks of treatment ] [ Designated as safety issue: No ]
1. The percentage change of fractional synthetic rate (FSR) of Apo A-1 from week 0 (baseline) to 6 weeks of treatment with NVP-based antiretroviral therapy. 2. Percentage change of flow mediated dilatation (FMD) from week 0 (baseline) to
Complete list of historical versions of study NCT00144261 on ClinicalTrials.gov Archive Site
  • Percentage change in the proteins involved in HDL metabolism [ Time Frame: after 6 and 24 weeks of treatment ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: from week 0 to 6, and 24 weeks of treatment ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: from week 0 to 24 weeks of treatment ] [ Designated as safety issue: No ]
Percent change, with NVP-based ART: 1. of FSR of Apo A-1 from week 0-24 2. in plasma levels of lipoproteins in fasting lipid panel from week 0- 6 and at week 24 3. in activity (and/or mass) of the constituents of the lipid enzymes panel at week 6 and 2
Not Provided
Not Provided
 
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
  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 ]

Not Provided
Interventional
Phase 4
Primary Purpose: Prevention
  • HIV Infections
  • Metabolism, Lipids
Drug: nevirapine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
Not Provided
December 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom
 
NCT00144261
1100.1426
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP