NCT02191332

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®).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2001

Completed
12.7 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

1.9 years

First QC Date

July 15, 2014

Last Update Submit

July 15, 2014

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (4)

  • 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)

    verbal rating scale

    Baseline, after 26 and 52 weeks

  • Change in glucose tolerance

    verbal rating scale

    Baseline, after 26 and 52 weeks

Secondary Outcomes (3)

  • Assessment of subjective well-being

    up to 52 weeks

  • Assessment of tolerability by physician and patient

    after 26 and 52 weeks

  • Number of patients with adverse events

    up to 52 weeks

Study Arms (1)

Viramune

Drug: Viramune

Interventions

ViramuneDRUG
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 or female patients with HIV type 1 infection

You may not qualify if:

  • 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

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

December 1, 1999

Primary Completion

November 1, 2001

Last Updated

July 16, 2014

Record last verified: 2014-07