QoL and Adherence to One-pill Once-a-day HAART | NCT00990600

Studies
QoL and Adherence to One-pill Once-a-day HAART

NCT00990600

Sponsor

A.O. Ospedale Papa Giovanni XXIII

Status

Completed

Last Update Posted

Oct 29, 2009Estimated

Enrollment

212Actual

Phase

Phase 3

Conditions

HIV Infection
HIV Infections

Interventions

reduced number of pills

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EUDRACT NUMBER: 2007-007839-33

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Oct 6, 2009

First Submission Date that Met QC Criteria

Oct 6, 2009

First Posted Date

Oct 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2009

Last Update Posted Date

Oct 29, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Primary objective of the study is:

To verify if simplification of the antiretroviral regimen, measured as the reduction of pill burden alone, may affect adherence rate of patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

212Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simplified one pill regimen	Experimental	Fixed dose combination of tenofovir + emtricitabine + efavirenz	Other: reduced number of pills

Interventions

Name	Type	Description	Arm Group Labels	Other Names
reduced number of pills	Other	Switch to a fixed dose combination one pill/daily HAART	Simplified one pill regimen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of adherence to HAART		6 months

Secondary Outcomes

Measure	Description	Time Frame
QoL (VAS scale) preferences of patients virologic and immunologic outcomes		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Informed consent signed
Effective ongoing treatment (HIV-RNA < 50 copies/ml) for at least three months
Being on a stable HAART regimen based either on two possible drug associations:
- 3TC/FTC + TDF + EFV
- FTC/TDF (fixed dose combination) + EFV
No previous documented virologic failure

Exclusion Criteria:

Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
Any ongoing grade 4 laboratory abnormality

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Franco Maggiolo, MD	Ospedali Riuniti, Bergamo	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C098320	efavirenz
C075889	Racivir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided