Randomised trial comparing the introduction of an immediate or deferred new HAART regimen in failing HIV infected patients: the role of lamivudine monotherapy - ND

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-010189-48-IT

Enrollment

280

Registered

2009-02-09

Start date

2009-03-13

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

HIV infected patients MedDRA version: 9.1 Level: LLT Classification code 10000807 Term: Acute HIV infection

Interventions

Trade Name: EPIVIR Pharmaceutical Form: Coated tablet INN or Proposed INN: Lamivudine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Trade Name: ATRIPLA Phar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: adukt patients affected by HIV in unchanged antiretroviral therapy from at least 12 weeks, in virologic failure with HI84V mutation 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: positivity for Hb3AQ; active opportunistic infections; pregnancy;

Design outcomes

Primary

Measure	Time frame
Main Objective: to verify if 6 months of monotherapy with Lamivudine followed by 6 months of HAART therapy has better virologic efficacy at 48 week in confront with 48 weeks of HAART therapy.;Secondary Objective: -to evaluate immunological and metabolical changes; -to evaluate the types and numbers of mutations associated to drug resistance; -evaluation of CDC o B events and deaths;;Primary end point(s): evaluation at week 48 of treatment of the parcent of patients in virologic suppression in the 2 different group of therapy	—

Measure

Time frame

Main Objective: to verify if 6 months of monotherapy with Lamivudine followed by 6 months of HAART therapy has better virologic efficacy at 48 week in confront with 48 weeks of HAART therapy.;Secondary Objective: -to evaluate immunological and metabolical changes; -to evaluate the types and numbers of mutations associated to drug resistance; -evaluation of CDC o B events and deaths;;Primary end point(s): evaluation at week 48 of treatment of the parcent of patients in virologic suppression in the 2 different group of therapy

—

Countries

Italy

Outcome results

None listed

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