Human immunodeficiency virus (HIV) infection Infections and Infestations Human immunodeficiency virus (HIV)
Conditions
Interventions
Patients are randomly assigned to receive either:
1. Retrovir (AZT) + Lamivudine (3TC) + Trizivir (ABC) + Efavirenz (Sustiva), or
2. AZT + 3TC + ABC + Lopinavir/Ritonavir (Kaletra)
After 24 weeks, p
Sponsors
Sponsor not yet defined (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female 2. HIV-1 infection 3. Age 18 or above 4. Antiretroviral-naive 5. Plasma viral load above 10,000 copies/ml 6. Life expectancy >72 weeks 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy, breastfeeding or intention to become pregnant during the study planned duration 2. Current opportunistic infection requiring parenteral therapy 3. Any formal contraindication to receive the study drugs 4. Current treatment with investigational drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with viral load below 20 copies/ml (polymerase chain reaction [PCR] estandar, Amplicor Monitor Roche Ultrasensible) at 72 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with CD4+ cell count above 200 c/ml at 72 weeks 2. Proportion of patients with viral load <20 copies/ml at 24 weeks 3. Time to treatment failure 4. Duration of response 5. Incidence of adverse events (clinical and laboratory) leading to discontinuation of the study drugs 6. Incidence of C events (CDC 1993) 7. Death for any cause | — |
Countries
Spain
Outcome results
None listed