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	https://doi.org/10.1186/ISRCTN04750658
Secondary identifying numbers	ARV/01

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Daniel Podzamczer
Scientific

Infectious Disease Service
Hospital Universitari de Bellvitge
c/Feixa Llarga s/n
L'Hospitalet
Barcelona
08907
Spain

Email	dpodzamczer@csub.scs.es

Study design	Randomised open multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	ABCDE study
Study objectives	To assess lipoatrophy, other toxicities, and efficacy associated with abacavir as compared with stavudine in HIV-infected antiretroviral-naive patients.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Stavudine, abacavir
Primary outcome measure	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 study start date	15/01/2001
Completion date	15/01/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	232 patients (116 per arm)
Key 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
Key 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
Date of first enrolment	15/01/2001
Date of final enrolment	15/01/2004

Infectious Disease Service

Barcelona
08907
Spain

Network of Research on AIDS (Red de Investigacion en SIDA [RIS]) (Spain)
Research organisation

IDIBAPS
c/Villarroel 170
Barcelona
08036
Spain

Research organisation

Network of Research on AIDS (Red de Investigacion en SIDA [RIS]) (Spain)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/02/2007		Yes	No