MedTrace Logo

CSP #512 - Options in Management With Anti-Retrovirals

NCT00050089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2015-04-23

Study results available
· View outcomes & findings →

Summary

This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including all three classes of anti-HIV drugs. The first randomization will allocate patients to an intended 3-month antiretroviral drug-free period (ARDFP) or No ARDFP. The second randomization will allocate patients to Mega-ART (5+ drugs) or to Standard-ART (up to 4 drugs). The total study duration is 6.5 years with 5 years of intake and 1.5 year (minimum) of follow-up; median duration of patient follow-up is about 4 years. The target sample size is 390 patients and will provide 75% power to detect a 30% reduction in the hazard rate for the primary endpoint with mega-ART. Sixty-four sites will be participating in the trial--24 VA, 19 UK and 21 Canada.

Conditions

  • AIDS
  • HIV Infections

Interventions

OTHER

No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP

Continuation or interruption of ART treatment

DRUG

Standard ART vs Mega ART

Standard therapy vs Intensified therapy

OTHER

No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP

Continuation or interruption of ART treatment

DRUG

Standard ART vs Mega ART

Standard therapy vs Intensified therapy

OTHER

No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP

Continuation or interruption of ART treatment

DRUG

Standard ART vs Mega ART

Standard therapy vs Intensified therapy

OTHER

No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP

Continuation or interruption of ART treatment

DRUG

Standard ART vs Mega ART

Standard therapy vs Intensified therapy

Sponsors & Collaborators

Principal Investigators

  • Sheldon Brown · VA Medical Center, Bronx

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00050089 on ClinicalTrials.gov