Condition category
Infections and Infestations
Date applied
20/10/2005
Date assigned
08/11/2005
Last edited
20/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

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

Sponsor details

IDIBAPS
c/Villarroel 170
Barcelona
08036
Spain

Sponsor type

Research organisation

Website

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

  1. 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.

Additional files

Editorial Notes