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Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily
This study has been completed.
Sponsor:
Germans Trias i Pujol Hospital
Collaborator:
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00314626
First received: April 12, 2006
Last updated: January 25, 2008
Last verified: November 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: efavirenz Drug: Abacavir+lamivudine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily |
Resource links provided by NLM:
Further study details as provided by Germans Trias i Pujol Hospital:
Primary Outcome Measures:
- Viral load of HIV-1 at each visit with regard to the baseline visit. [ Time Frame: At 12, 24, 36 and 48 weeks ]
Secondary Outcome Measures:
- To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period. [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: At 12, 24, 36 and 48 weeks ]
| Enrollment: | 99 |
| Study Start Date: | November 2004 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h
|
Drug: efavirenz
Efavirenz
Other Name: sustiva
Drug: Abacavir+lamivudine
Abacavir+lamivudine
Other Name: Kivexa
|
|
No Intervention: B
efavirenz + 2 NUCS
|
Detailed Description:
Treatment simplification is a therapeutic strategy that allows patients with controlled viral replication to switch to an easier-to-take antiretroviral system to promote long-term adherence and thus maintain controlled viral load for longer, delaying the evolution of the HIV infection.
The combination of ABC+3TC+EFV is a potent and easy-to-take regimen (2 tablets once a day) that could be suitable for the simplification of antiretroviral treatment in patients with controlled viral load with a regimen that includes 2 NRTI taken twice daily.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314626
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314626
Locations
| Spain | |
| Germans Trias i Pujol Hospital | |
| Badalona, Barcelona, Spain, 08916 | |
| Hospital de Mataró | |
| Mataro, Barcelona, Spain, 08304 | |
| Hospital de Aranzazu | |
| San Sebastian, Guipuzcoa, Spain, 20014 | |
| Hospital San Millan de Logroño | |
| Logroño, La Rioja, Spain, 26001 | |
| Hospital Principe de Asturias | |
| Alcala de Henares, Madrid, Spain, 28005 | |
| Hospital de Móstoles | |
| Mostoles, Madrid, Spain, 28935 | |
| Hospital Costa del Sol | |
| Marbella, Málaga, Spain, 29600 | |
| Hospital Universitario de Canarias | |
| La Laguna, Santa Cruz de Tenerife, Spain, 38320 | |
| Hospital de la Vall d'Hebron | |
| Barcelona, Spain, 08035 | |
| Hospital Virgen de las Nieves | |
| Granada, Spain, 18014 | |
| Hospital Arnau de Vilanova de Lleida | |
| Lleida, Spain, 25198 | |
| Hospital Severo Ochoa Leganés | |
| Madrid, Spain, 28911 | |
| Hospital Cristal-Piñor | |
| Ourense, Spain, 32005 | |
| Hospital Santa María Nai | |
| Ourense, Spain, 32005 | |
| Hospital de Navarra | |
| Pamplona, Spain, 31008 | |
| Hospital General de Valencia | |
| Valencia, Spain, 46014 | |
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Investigators
| Principal Investigator: | Bonaventura Clotet, MD, PhD | Lluita contra la Sida Foundation-HIV Unit |
More Information
| Responsible Party: | LLuita Sida Foundation |
| ClinicalTrials.gov Identifier: | NCT00314626 History of Changes |
| Other Study ID Numbers: |
ELA 2004-001198-25 |
| Study First Received: | April 12, 2006 |
| Last Updated: | January 25, 2008 |
Keywords provided by Germans Trias i Pujol Hospital:
|
Antiviral efficacy Tolerability Immunologic response Virologic response HIV |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Efavirenz Abacavir Dideoxynucleosides Reverse Transcriptase Inhibitors |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antimetabolites |
ClinicalTrials.gov processed this record on September 19, 2017