NCT00990600

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3

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

April 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2009

Completed
Last Updated

October 29, 2009

Status Verified

October 1, 2009

Enrollment Period

1.1 years

First QC Date

October 6, 2009

Last Update Submit

October 28, 2009

Conditions

HIV InfectionHIV Infections

Keywords

adherenceQolvirologic efficacyimmunologic efficacypatients' preferenceonce-dailyHAARTtreatment experienced

Outcome Measures

Primary Outcomes (1)

  • Proportion of adherence to HAART

    6 months

Secondary Outcomes (1)

  • QoL (VAS scale) preferences of patients virologic and immunologic outcomes

    6 months

Study Arms (1)

Simplified one pill regimen

EXPERIMENTAL

Fixed dose combination of tenofovir + emtricitabine + efavirenz

Other: reduced number of pills

Interventions

reduced number of pillsOTHER

Switch to a fixed dose combination one pill/daily HAART

Also known as: efavirenz EFV, emtricitabine FTC, tenofovir TDF
Simplified one pill regimen

Eligibility Criteria

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

You may qualify if:

  • 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:
  • TC/FTC + TDF + EFV
  • FTC/TDF (fixed dose combination) + EFV
  • No previous documented virologic failure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenzRacivir

Condition Hierarchy (Ancestors)

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

Study Officials

  • Franco Maggiolo, MD

    Ospedali Riuniti, Bergamo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2009

First Posted

October 7, 2009

Study Start

April 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

October 29, 2009

Record last verified: 2009-10