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

N/ACompletedNCT02191332

Boehringer Ingelheim147 enrolled

Overview

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®).

Study Type

OBSERVATIONAL

Enrollment

147

Conditions

HIV Infections

Interventions

ViramuneDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in viral load (HIV-RNA)

Time frame: Baseline, after 26 and 52 weeks

Change in CD4 cell count

Time frame: Baseline, after 26 and 52 weeks

Change in lipid status (lipodystrophy, triglycerides, cholesterol)

verbal rating scale

Time frame: Baseline, after 26 and 52 weeks

Change in glucose tolerance

verbal rating scale

Time frame: Baseline, after 26 and 52 weeks

Secondary Outcomes

Assessment of subjective well-being

verbal rating scale

Time frame: up to 52 weeks

Assessment of tolerability by physician and patient

verbal rating scale

Time frame: after 26 and 52 weeks

Number of patients with adverse events

Time frame: up to 52 weeks

Data from ClinicalTrials.gov

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