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Randomised open multicentre trial comparing stavudine versus abacavir, both combined with lamivudine/efavirenz, in Human Immunodeficiency Virus (HIV) infected antiretroviral naïve patients
ISRCTN ISRCTN04750658
DOI 10.1186/ISRCTN04750658
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised open multicentre trial comparing stavudine versus abacavir, both combined with lamivudine/efavirenz, in Human Immunodeficiency Virus (HIV) infected antiretroviral naïve patients
Scientific title
Acronym ABCDE study
Serial number at source ARV/01
Study hypothesis To assess lipoatrophy, other toxicities, and efficacy associated with abacavir as compared with stavudine in HIV-infected antiretroviral-naive patients.
Lay summary
Ethics approval Not provided at time of registration.
Study design Randomised open multicentre trial
Countries of recruitment Spain
Disease/condition/study domain Human immunodeficiency virus (HIV) infection
Participants - inclusion criteria 1. HIV positive confirmed by Western blot
2. Adult 18 - 70 years
3. No previous antiretroviral therapy
4. HIV-1 Ribonucleic Acid (RNA) greater than 1500 copies/ml (Polymerase Chain Reaction [PCR], Nucleic Acid Sequence Based Amplification [NASBA] or branched-chain Deoxyribonucleic Acid [bDNA]) within 12 weeks prior to study initiation
5. Written informed consent
Participants - exclusion criteria 1. Prior antiretroviral therapy
2. Concomitant participation in another clinical trial
3. Signs of hepatic cirrhosis
4. Any of the following laboratory parameter alterations:
4.1. Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than 5 times above the normal values
4.2. Creatinine clearance less than 50 ml/min
4.3. Amylases greater than 3 times above normal values
4.4. Hemoglobin less than 8 mg/dl
4.5. Neutrophils less than 500/µl
4.6. Platelets less than 30,000/µl
5. Pregnancy
6. Contraindicated drugs
7. Active infection within the last 4 weeks
8. Treatment for neoplasms
Anticipated start date 15/01/2001
Anticipated end date 15/01/2004
Status of trial Completed
Patient information material
Target number of participants 232 patients (116 per arm)
Interventions Patients will centrally be stratified according to HIV-1 RNA greater than or less than or equal to 30,000 copies/ml and CD4 counts greater than or less than or equal to 200 cells/µl; and randomised to one of these arms:
1. Abacavir 300 mg twice a day (bid), plus lamivudine 150 mg bid, plus efavirenz 600 mg once a day (qd)
2. Stavudine 30 - 40 mg bid (according to less than or more than 60 kg body weight) plus lamivudine and efavirenz at the same doses as group 1
Primary outcome measure(s) Proportion of patients with lipoatrophy as assessed by physician and patient observation at 96 weeks.
Secondary outcome measure(s) 1. Virological, clinical and immunological efficacy
2. Tolerability
Sources of funding Network of Research on AIDS (Red de Investigacion en SIDA [RIS]) (Spain)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17106274
Contact name Dr  Daniel  Podzamczer
  Address Infectious Disease Service
Hospital Universitari de Bellvitge
c/Feixa Llarga s/n
L'Hospitalet
  City/town Barcelona
  Zip/Postcode 08907
  Country Spain
  Email dpodzamczer@csub.scs.es
Sponsor Network of Research on AIDS (Red de Investigacion en SIDA [RIS]) (Spain)
  Address IDIBAPS
c/Villarroel 170
  City/town Barcelona
  Zip/Postcode 08036
  Country Spain
Date applied 20/10/2005
Last edited 20/11/2007
Date ISRCTN assigned 08/11/2005
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