NCT02191293

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
Last Updated

July 16, 2014

Status Verified

July 1, 2014

Enrollment Period

4.3 years

First QC Date

July 15, 2014

Last Update Submit

July 15, 2014

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

  • Changes in viral load (HIV-RNA)

    Baseline, up to 36 months

  • Changes in CD4 cell count

    Baseline, up to 36 months

Secondary Outcomes (6)

  • Changes in body weight

    Baseline, up to 36 months

  • Changes in general well-being assessed on a 4-point scale

    Baseline, up to 36 months

  • Changes in lipid parameters

    Baseline, up to 36 months

  • Changes in glucose

    Baseline, up to 36 months

  • Changes in liver enzymes

    Baseline, up to 36 months

  • +1 more secondary outcomes

Study Arms (1)

Viramune®

Drug: Viramune® tablets

Interventions

Viramune® tabletsDRUG
Viramune®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV treatment centres and HIV out-patient facilities

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic 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

May 1, 2002

Primary Completion

September 1, 2006

Last Updated

July 16, 2014

Record last verified: 2014-07