A RANDOMIZED, MULTICENTER STUDY OF USE INTERMITTENT HAART HIGHLY ACTIVE ANTIRETROVIRAL THERAPY THERAPY VERSUS CONTINUATIVE HAART THERAPY IN HIV PATIENTS - ND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001621-26-IT

Enrollment

438

Registered

2006-11-10

Start date

2006-03-13

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

PATIENTS POSITIVE HIV TO LOW RISK OF DEVELOPMENT OF OPPORTUNISTIC PATHOLOGIES CORRELATED-HIV. MedDRA version: 6.1 Level: HLT Classification code 10052740

Interventions

Pharmaceutical Form: Capsule, soft Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 SUPERIOR AGE TO 18; 2 THERAPY HAART FROM AT LEAST 12 MONTHS, WITH VALUES OF CD4 OR 500/mmc; 3 PATIENTS IN HAART THERAPY NOT IN FAILURE VIROLOGIC; 4 NADIR OF CD4 OR TO 200/mmc; 5 SIGNATURE OF INFORMED CONSENT. Are the trial subjects under 18? no 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: 1 SHARE TO OTHER CLINICAL STUDY; 2 CHRONIC HBV HEPATITIS; 3 SMALLER NADIR OF THE CD4 200/mmc; 4 PREGNANCY; 5 PRECEDENT DEFINING PATHOLOGY THE AIDS.

Design outcomes

Primary

Measure	Time frame
Main Objective: TO VALUE THE SAFETY OF THE SUSPENSION HAART THERAPY PRACTICE COMPARED TO THE CONTINUOUS TREATMENT IN THE PATIENTS;Primary end point(s): CALCULATION OF THE FREQUENCY OF GREAT OPPORTUNISTIC PATHOLOGIES, APPEARED OF ADVERSE EVENTS OF DEGREE 3-4, FREQUENCY OF THE FAILURES OF THE THERAPY IN THE TWO ARMS OF THE STUDY.;Secondary Objective: TO VALUE IN THE PATIENTS THAT SUSPEND THE TREATMENT 1 THE CORRELATED PARAMETERS WITH THE DURATION OF THE SUSPENSION OF THE THERAPY; 2 THE BEHAVIOR OF THE CD4 AFTER THE INTERRUPTION OF THE THERAPY; 3 THE IMMUNOLOGICAL ANSWER AND VIROLOGICAL TO THE RESUMPTION OF THE THERAPY; 4 THE DURATION OF THE FOLLOWING INTERRUPTIONS TO THE FIRST ONE ; 5 THE GENERAL TIME OF SUSPENSION OF THE TREATMENT; 6 THE QUALITY OF LIFE	—

Measure

Time frame

Main Objective: TO VALUE THE SAFETY OF THE SUSPENSION HAART THERAPY PRACTICE COMPARED TO THE CONTINUOUS TREATMENT IN THE PATIENTS;Primary end point(s): CALCULATION OF THE FREQUENCY OF GREAT OPPORTUNISTIC PATHOLOGIES, APPEARED OF ADVERSE EVENTS OF DEGREE 3-4, FREQUENCY OF THE FAILURES OF THE THERAPY IN THE TWO ARMS OF THE STUDY.;Secondary Objective: TO VALUE IN THE PATIENTS THAT SUSPEND THE TREATMENT 1 THE CORRELATED PARAMETERS WITH THE DURATION OF THE SUSPENSION OF THE THERAPY; 2 THE BEHAVIOR OF THE CD4 AFTER THE INTERRUPTION OF THE THERAPY; 3 THE IMMUNOLOGICAL ANSWER AND VIROLOGICAL TO THE RESUMPTION OF THE THERAPY; 4 THE DURATION OF THE FOLLOWING INTERRUPTIONS TO THE FIRST ONE ; 5 THE GENERAL TIME OF SUSPENSION OF THE TREATMENT; 6 THE QUALITY OF LIFE

—

Countries

Italy

Outcome results

None listed

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