NCT00314626

Brief Summary

To evaluate the proportion of patients with virological failure after 48 weeks of treatment with the combination of efavirenz 600 mg + lamivudine (3TC) 300 mg + abacavir 600 mg once daily as an antiretroviral simplification regimen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_3 hiv-infections

Geographic Reach
1 country

16 active sites

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, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 29, 2008

Status Verified

November 1, 2007

Enrollment Period

2.3 years

First QC Date

April 12, 2006

Last Update Submit

January 25, 2008

Conditions

HIV Infections

Keywords

Antiviral efficacyTolerabilityImmunologic responseVirologic responseHIV

Outcome Measures

Primary Outcomes (1)

  • Viral load of HIV-1 at each visit with regard to the baseline visit.

    At 12, 24, 36 and 48 weeks

Secondary Outcomes (3)

  • To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period.

    At 12, 24, 36 and 48 weeks

  • To evaluate the tolerance and safety of the combination of abacavir+ lamivudine (in a single tablet) + efavirenz given once daily over 48-week treatment period.

    At 12, 24, 36 and 48 weeks

  • To evaluate treatment adherence (assessed by a self-reported questionnaire and with graduated satisfaction scales) and patient quality of life (assessed by means of the MOS-HIV questionnaire).

    At 12, 24, 36 and 48 weeks

Study Arms (2)

A

EXPERIMENTAL

abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h

Drug: efavirenzDrug: Abacavir+lamivudine

B

NO INTERVENTION

efavirenz + 2 NUCS

Interventions

efavirenzDRUG

Efavirenz

Also known as: sustiva
A
Abacavir+lamivudineDRUG

Abacavir+lamivudine

Also known as: Kivexa
A

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years.
  • HIV-1 infected patients.
  • Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least.
  • Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months).
  • Subject able to follow the treatment period.
  • Signature of the informed consent.
  • Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.

You may not qualify if:

  • Hepatic tests \> 5 times above normality.
  • Pregnancy or breastfeeding
  • Presence of opportunistic infections and/or recent tumours (\< 6 months).
  • Suspected or documented resistance to any of the investigational drugs.
  • Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
  • Subjects with abusive consumption of alcohol or illegal drugs.
  • Patients participating in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Hospital de la Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

Hospital Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Hospital de Aranzazu

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Hospital San Millan de Logroño

Logroño, La Rioja, 26001, Spain

Location

Hospital Arnau de Vilanova de Lleida

Lleida, Lleida, 25198, Spain

Location

Hospital Principe de Asturias

Alcalá de Henares, Madrid, 28005, Spain

Location

Hospital Severo Ochoa Leganés

Madrid, Madrid, 28911, Spain

Location

Hospital de Móstoles

Móstoles, Madrid, 28935, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, 29600, Spain

Location

Hospital Cristal-Piñor

Ourense, Ourense, 32005, Spain

Location

Hospital Santa María Nai

Ourense, Ourense, 32005, Spain

Location

Hospital de Navarra

Pamplona, Pamplona, 31008, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

Location

Hospital General de Valencia

Valencia, Valencia, 46014, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenzabacavir, lamivudine drug combination

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

  • Bonaventura Clotet, MD, PhD

    Lluita contra la Sida Foundation-HIV Unit

    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

April 12, 2006

First Posted

April 14, 2006

Study Start

November 1, 2004

Primary Completion

February 1, 2007

Study Completion

March 1, 2007

Last Updated

January 29, 2008

Record last verified: 2007-11

Locations

ES(16)