Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00127972




Registration number
NCT00127972
Ethics application status
Date submitted
8/08/2005
Date registered
9/08/2005
Date last updated
30/04/2007

Titles & IDs
Public title
2NN & CHARM Long-Term Follow-up Study
Scientific title
A Retrospective Study to Compare the 3-Year Antiviral Efficacy of Nevirapine and Efavirenz in Combination With D4t and 3tc in 2NN Patients and of Trizivir Versus Trizivir Plus Nevirapine in CHARM Patients
Secondary ID [1] 0 0
04IAT0035
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - stavudine
Treatment: Drugs - lamivudine
Treatment: Drugs - nevirapine
Treatment: Drugs - efavirenz
Treatment: Drugs - trizivir

Treatment: Drugs: stavudine


Treatment: Drugs: lamivudine


Treatment: Drugs: nevirapine


Treatment: Drugs: efavirenz


Treatment: Drugs: trizivir
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine whether the number of patients with treatment failure after 144 weeks of follow-up is different between study arms
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To determine whether the percentage of patients with treatment failure after 144 weeks of follow-up is different between the treatment arms
Timepoint [1] 0 0
Secondary outcome [2] 0 0
To determine whether the percentage of patients with virologic failure after 144 weeks of follow-up is different between the treatment arms
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- Participation in the original 2NN or CHARM study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- None

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2007
Sample size
Target
Accrual to date
Final
763
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment postcode(s) [1] 0 0
NSW2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
International Antiviral Therapy Evaluation Center
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Boehringer Ingelheim
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00127972
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joep MA Lange, MD PhD
Address 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00127972