Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen

Collecting Data in Patients With HIV Infection Type 1 After Switching From a Protease Inhibitor-containing Therapy Regimen and a Viral Load Below Detection Level to a Viramune®-Containing Therapy Regimen

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02191332

Enrollment

147

Registered

2014-07-16

Start date

1999-12-31

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

Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).

Interventions

DRUGViramune

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult male or female patients with HIV type 1 infection

Exclusion criteria

* Counter-indications according to summary of product characteristics (SPC) for Viramune tablets * No persons under 18 * Pregnancy and breast-feeding * Use of oral contraceptives * Use of drugs affecting CYP450 3A metabolism

Design outcomes

Primary

Measure	Time frame	Description
Change in glucose tolerance	Baseline, after 26 and 52 weeks	verbal rating scale
Change in viral load (HIV-RNA)	Baseline, after 26 and 52 weeks	—
Change in CD4 cell count	Baseline, after 26 and 52 weeks	—
Change in lipid status (lipodystrophy, triglycerides, cholesterol)	Baseline, after 26 and 52 weeks	verbal rating scale

Secondary

Measure	Time frame	Description
Assessment of tolerability by physician and patient	after 26 and 52 weeks	verbal rating scale
Number of patients with adverse events	up to 52 weeks	—
Assessment of subjective well-being	up to 52 weeks	verbal rating scale

Outcome results

None listed

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