2NN & CHARM Long-Term Follow-up Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00127972
• Date of registration: 08/08/2005
• Primary sponsor: International Antiviral Therapy Evaluation Center
• 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
• Date of first enrolment: February 2004
• Target sample size: 763
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00127972
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Countries of recruitment

Australia

Contacts

• Name: Joep MA Lange, MD PhD
• Affiliation: Academic Medical Center Amsterdam

• Name: Mark Bloch, MD
• Affiliation: Holdsworth House General Practice

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participation in the original 2NN or CHARM study

Exclusion Criteria:

- None



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: efavirenz

Drug: lamivudine

Drug: nevirapine

Drug: stavudine

Drug: trizivir

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

04IAT0035

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boehringer Ingelheim Pharmaceuticals