Human immunodeficiency virus (HIV) infection Infections and Infestations Human immunodeficiency virus (HIV)
Conditions
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
Sponsors
Network of Research on AIDS (Red de Investigacion en SIDA [RIS]) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with lipoatrophy as assessed by physician and patient observation at 96 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Virological, clinical and immunological efficacy 2. Tolerability | — |
Countries
Spain
Outcome results
None listed