Observational Study With Antiretroviral Treated Patients Switching to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens

NCT02191319 | Completed

• 1 other identifier: 1100.1395
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (4)

• Change in viral load (HIV-RNA)

  Baseline, up to 52 weeks

• Change in CD4 cell count

  Baseline, up to 52 weeks

• Change in lipid parameters

  mg/dl

  Baseline, up to 52 weeks

• Change in glucose

  mg/dl

  Baseline, up to 52 weeks

Secondary Outcomes (4)

• Assessment of subjective well-being

  up to 52 weeks

• Assessment of tolerability by physician and patients

  after 52 weeks

• Change in liver enzyme parameter

  Baseline, up to 52 weeks

• Number of patients with adverse events

  up to 52 weeks

Study Arms (1)

Viramune®

Patients switching from protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) containing antiretroviral regimen to Viramune®

Drug: Viramune®

Interventions

Viramune® DRUG

Viramune®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV treatment centres and HIV out-patient facilities

You may qualify if:

• Patients suffer from HIV type 1 infection
• Patient is treated with antiretroviral protease-inhibitors or non-nucleoside reverse transcriptase inhibitors
• Patient has shown a depression of viral load before limit of detection (\< 50 HIV-RNA copies/ml) for more than 6 months prior to visit 1
• Patient is male or female with age greater than or equal to 18 years
• Women have to be willing to use an effective barrier method of contraception for the duration of the observational study participation

You may not qualify if:

• Patient has clinically relevant laboratory findings (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> five times upper limit of normal (ULN))
• Patients is hypersensitive to Viramune® or to any of its excipients
• Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, or other drug affecting CYP3A-metabolism
• Patients is breast-feeding
• Patient is pregnant
• Patient is a woman and does not use effective contraception

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 16, 2014
• Study Start: January 1, 2002
• Primary Completion: August 1, 2004
• Last Updated: July 16, 2014

Record last verified: 2014-07