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Completed

NCT Number: NCT00314626

Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Germans Trias i Pujol Hospital, Badalona, Barcelona, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Efavirenz

Drug

Efavirenz

Other names: sustiva

Abacavir+Lamivudine

Drug

Abacavir+lamivudine

Other names: Kivexa

Primary outcomes

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

    Time frame: At 12, 24, 36 and 48 weeks

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Collaborators

  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Registry information

Official study title

Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Apr 14, 2006
Registry last updated
Jan 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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