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HIV InfectionsPhase 4NCT00144261

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

A Phase 4 study testing nevirapine in people with HIV Infections and Metabolism, Lipids, run by Boehringer Ingelheim at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Metabolism, Lipids
What is being tested?
nevirapine
How many people
15 participants
Where
3 sitesin 2 countries
Study dates
1 Nov 2003to 1 Dec 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Netherlands2 sites

  • 1100.1426.01 Academic Medical Centre

    Amsterdam

  • 1100.1426.02 Onze Lieve Vrouwe Gasthuis

    Amsterdam

Other trials in Netherlands

United Kingdom1 site

  • 1100.1426.44001 Boehringer Ingelheim Investigational Site

    London

Other trials in United Kingdom

About this study

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

  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 ]

Being tested
nevirapine
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nevirapineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change of fractional synthetic rate (FSR) of Apo A-1

    Measured: after 6 weeks of treatment

  2. Percentage change of flow mediated dilatation (FMD)

    Measured: after 6 and 24 weeks of treatment

Secondary outcomes (3)

  1. Percentage change in the proteins involved in HDL metabolism

    Measured: after 6 and 24 weeks of treatment

  2. 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

    Measured: from week 0 to 6, and 24 weeks of treatment

  3. 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

    Measured: from week 0 to 24 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2005 (estimated)
  2. Study start1 Nov 2003
  3. Primary completion1 Dec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00144261
Sponsor's protocol ID
1100.1426
Status last verified
Jan 2025
First submitted
2 Sep 2005
Last updated
31 Jan 2025
Results posted
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing nevirapine in people with HIV Infections and Metabolism, Lipids, run by Boehringer Ingelheim at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change of fractional synthetic rate (FSR) of Apo A-1 (time frame: after 6 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00144261.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.

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