NCT00310245

Brief Summary

This is a single center, independent study. The primary objective is to compare efficacy and safety of continuing a conventional HAART in chronically infected HIV patients with a therapeutic strategy based on long term, immunologically driven treatment interruptions. Evaluation will be based on clinical, immunological and virological response. Patients will be randomized in a ratio 1:2 to one of the two treatment arms: Control group continuing the ongoing therapy STI group performing long term CD4 guided structured treatment interruptions In the STI arm patients will stay off therapy until their CD4 count will drop \< 400 cells/mcL. At that time point patients will resume the HAART regimen they were assuming before STI and will continue HAART until they CD4 count will raise \> 800 cells/mcL and their HIV-RNA will drop below the detection limit of 50 copies/ml. When both the CD4 count and the viral load will be within these pre-set values they will stop therapy again. There is no limit to the number of interruptions and re-start cycles during the study period The study is powered to evaluate equivalence between the two strategies under the assumption of a failure proportion in the control arm at each time point not greater than 5% and a maximum allowed difference of 15%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
Last Updated

July 24, 2006

Status Verified

November 1, 2005

First QC Date

March 31, 2006

Last Update Submit

July 21, 2006

Conditions

HIV Infection

Keywords

CD4-guided STIKeywords:HAARTClinical outcomeResistanceCostsPrognostic factorspulse therapytreatment experiencedtreatment interruption

Outcome Measures

Primary Outcomes (3)

  • Proportion of subjects maintaining at each time-point a CD4 + cell count above 400 cells/mcL.

  • Occurrence of clinical end-points (AIDS defining event and death)

  • Virologic failure with the selection of resistance conferring mutations.

Secondary Outcomes (5)

  • Mean variation of blood cholesterol and triglycerides from baseline values. For these parameters the proportion of subjects with a value above grade 2 (AHA) will be also used as evaluation criteria.

  • Development of lipodystrophy or modification of a pre-existing lipodystrophy

  • Time off therapy

  • Economic evaluation

  • Genotypic tests to be performed in the case of HIV-RNA > 1000 copies/ml while on therapy for at least 4 months or one month after each treatment interruption.

Interventions

STI (structured Treatment Interruption)PROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • i. Age \> 17 years ii. Informed consent signed iii. Effective ongoing treatment (HIV-RNA \< 50 copies/ml). Treatment must be based on any triple drug therapy. Patients must be on the same steady therapy for at least 3 months.
  • iv. Current CD4 cell count above 800 cells/L

You may not qualify if:

  • iii. Previous use of immunomodulatory agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antiviral Therapy Unit, Ospedali Riuniti

Bergamo, Bergamo, 24128, Italy

Location

Related Publications (1)

  • Maggiolo F, Ripamonti D, Gregis G, Quinzan G, Callegaro A, Suter F. Effect of prolonged discontinuation of successful antiretroviral therapy on CD4 T cells: a controlled, prospective trial. AIDS. 2004 Feb 20;18(3):439-46. doi: 10.1097/00002030-200402200-00010.

    PMID: 15090796RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Treatment Interruption

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Treatment Adherence and ComplianceAttitude to HealthDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Franco Maggiolo, MD

    Ospedali Riuniti, Bergamo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2006

First Posted

April 3, 2006

Study Start

November 1, 2000

Study Completion

November 1, 2005

Last Updated

July 24, 2006

Record last verified: 2005-11

Locations

IT(1)