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| [ Print-friendly version ] |
| Randomised open multicentre trial comparing stavudine versus abacavir, both combined with lamivudine/efavirenz, in Human Immunodeficiency Virus (HIV) infected antiretroviral naïve patients |
| ISRCTN | ISRCTN04750658 |
| ClinicalTrials.gov identifier | |
| 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 |
| 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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| © 2012 ISRCTN unless otherwise stated. | |
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