A retrospective study to compare the 3-year antiviral efficacy of nevirapine and efavirenz in combination with D4T and 3TC in 2NN patients - 2NN Follow-up study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000623-16-GB

Enrollment

750

Registered

2005-02-17

Start date

2004-12-13

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of HIV-1 infection

Interventions

Trade Name: Viramune Product Name: Viramune Pharmaceutical Form: Tablet INN or Proposed INN: nevirapine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participation in the initial 2NN study (protocol 1100.1288) 2. Under active follow-up at the end of the initial 2NN study (i.e. at week 48), whether or not using randomized treatment. 3. Ability and willingness to give written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the trial is to determine whether the number of patients with treatment failure after 144 weeks of follow-up is different between nevirapine (twice daily) and efavirenz.;Secondary Objective: 1. To determine whether the number of patients with treatment failure after 144 weeks of follow-up is different between the four treatment arms. 2. To determine whether the percentage of patients with virological failure after 144 weeks of follow-up is different between the four treatment arms. 3. To determine whether the percentage of patients with pVL or equal to 50 copies/mL from week 24 onwards, or a pVL > or equal to 50 copies/mL at week 144; (2) CDC-C event from 8 weeks onwards or death; (3) change of allocated treatment	—

Measure

Time frame

Main Objective: The primary objective of the trial is to determine whether the number of patients with treatment failure after 144 weeks of follow-up is different between nevirapine (twice daily) and efavirenz.;Secondary Objective: 1. To determine whether the number of patients with treatment failure after 144 weeks of follow-up is different between the four treatment arms. 2. To determine whether the percentage of patients with virological failure after 144 weeks of follow-up is different between the four treatment arms. 3. To determine whether the percentage of patients with pVL or equal to 50 copies/mL from week 24 onwards, or a pVL > or equal to 50 copies/mL at week 144; (2) CDC-C event from 8 weeks onwards or death; (3) change of allocated treatment

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026