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Long-term Study in Patients U...

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

NCT ID: NCT02191293

Last Updated: 2014-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

228 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Viramune®

Viramune® tablets

Intervention Type DRUG

Interventions

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Viramune® tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers