NCT00127972

Brief Summary

It is desirable to obtain extended follow up data on subjects who participated in the 2NN study and the CHARM study in order to see if the beneficial effect of using nevirapine continues up to 144 weeks of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
763

participants targeted

Target at P75+ for phase_4 hiv-infections

Timeline
Completed

Started Feb 2004

Typical duration for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

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

February 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 30, 2007

Status Verified

April 1, 2007

First QC Date

August 8, 2005

Last Update Submit

April 27, 2007

Conditions

HIV Infections

Keywords

nevirapineefavirenzhiv-1Treatment Experienced

Outcome Measures

Primary Outcomes (1)

  • To determine whether the number of patients with treatment failure after 144 weeks of follow-up is different between study arms

Secondary Outcomes (2)

  • To determine whether the percentage of patients with treatment failure after 144 weeks of follow-up is different between the treatment arms

  • To determine whether the percentage of patients with virologic failure after 144 weeks of follow-up is different between the treatment arms

Interventions

stavudineDRUG
lamivudineDRUG
nevirapineDRUG
efavirenzDRUG
trizivirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participation in the original 2NN or CHARM study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holdsworth House Medical Practice

Darlinghurst, NSW2010, Australia

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

StavudineLamivudineNevirapineefavirenzabacavir, lamivudine, and zidovudine drug combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesZalcitabineDeoxycytidineCytidinePyridines

Study Officials

  • Joep MA Lange, MD PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    STUDY CHAIR

  • Mark Bloch, MD

    Holdsworth House General Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

February 1, 2004

Study Completion

April 1, 2007

Last Updated

April 30, 2007

Record last verified: 2007-04

Locations

AU(1)