Contact information
Type
Scientific
Primary contact
Dr Daniel Podzamczer
ORCID ID
Contact details
Infectious Disease Service
Hospital Universitari de Bellvitge
c/Feixa Llarga s/n
L'Hospitalet
Barcelona
08907
Spain
dpodzamczer@csub.scs.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ARV/01
Study information
Scientific title
Acronym
ABCDE study
Study hypothesis
To assess lipoatrophy, other toxicities, and efficacy associated with abacavir as compared with stavudine in HIV-infected antiretroviral-naive patients.
Ethics approval
Not provided at time of registration.
Study design
Randomised open multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Human immunodeficiency virus (HIV) infection
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
Stavudine, abacavir
Primary outcome measures
Proportion of patients with lipoatrophy as assessed by physician and patient observation at 96 weeks.
Secondary outcome measures
1. Virological, clinical and immunological efficacy
2. Tolerability
Overall trial start date
15/01/2001
Overall trial end date
15/01/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
232 patients (116 per arm)
Participant 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
Recruitment start date
15/01/2001
Recruitment end date
15/01/2004
Locations
Countries of recruitment
Spain
Trial participating centre
Infectious Disease Service
Barcelona
08907
Spain
Funders
Funder type
Research organisation
Funder name
Network of Research on AIDS (Red de Investigacion en SIDA [RIS]) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17106274
Publication citations
-
Results
Podzamczer D, Ferrer E, Sanchez P, Gatell JM, Crespo M, Fisac C, Lonca M, Sanz J, Niubo J, Veloso S, Llibre JM, Barrufet P, Ribas MA, Merino E, Ribera E, Martínez-Lacasa J, Alonso C, Aranda M, Pulido F, Berenguer J, Delegido A, Pedreira JD, Lérida A, Rubio R, del Río L, , Less lipoatrophy and better lipid profile with abacavir as compared to stavudine: 96-week results of a randomized study., J. Acquir. Immune Defic. Syndr., 2007, 44, 2, 139-147, doi: 10.1097/QAI.0b013e31802bf122.