Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®

Long-term Observational Study in Patients Under Anti-retroviral Combination Therapy Who Were Switched From Protease Inhibitors or Other NNRTI to Viramune® Plus Two Nucleoside Reverse Transcriptase Inhibitors (NRTI) for Reasons of Therapy. (Long-Term Switch)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02191293

Enrollment

228

Registered

2014-07-16

Start date

2002-05-31

Completion date

Unknown

Last updated

2014-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.

Interventions

DRUGViramune® tablets

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult male and female out-patients with HIV type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) * Women can only be included, if a test has excluded pregnancy * Only women can be included, who use a reliable means of contraception during the observational study

Exclusion criteria

* Known sensitivity to Viramune or one of its excipients * Clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of upper limit normal) * Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication CYP3A metabolism * For females: * Pregnancy * Breast-feeding * Insufficient or unreliable contraception

Design outcomes

Primary

Measure	Time frame
Changes in viral load (HIV-RNA)	Baseline, up to 36 months
Changes in CD4 cell count	Baseline, up to 36 months

Secondary

Measure	Time frame	Description
Changes in lipid parameters	Baseline, up to 36 months	mg/dl
Changes in glucose	Baseline, up to 36 months	mg/dl
Changes in body weight	Baseline, up to 36 months	—
Number of patients with adverse events	up to 36 months	—
Changes in liver enzymes	Baseline, up to 36 months	U/l
Changes in general well-being assessed on a 4-point scale	Baseline, up to 36 months	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026