HIV infection Infections and Infestations HIV infection
Conditions
Interventions
All participants will initiate an antiretroviral regimen of Trizivir® (Active ingredients: zidovudine 300 mg + lamivudine 150 mg + abacavir 300 mg) 1 pill orally twice a day (bid) plus tenofovir 300 m
Sponsors
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed HIV infection 2. Age >= 18 years 3. AntiRetroViral (ARV) naive 4. CD4 > 100 cells/uL 5. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Alanine aminotransferase >5 Upper Limit of Normal (ULN) 2. Hepatic cirrhosis 3. Renal insufficiency with creatinine clearance <50 ml/min 4. Haemoglobin (Hb) <9 g/dL 5. Neutrophils <1,000/uL 6. Platelets <30,000/uL 7. Pregnancy 8. Acute infection in the last two weeks 9. Systemic treatment for neoplasms 10. Hepatitis C Virus+ (HCV+) in patients who require treatment with interferon/ribavirin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viral load <50 copies/mL. Viral load is measured at baseline, week 2, 4, 12 and every 12 weeks thereafter up to the end of the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CD4 changes, measured at baseline, week 12 and every 12 weeks thereafter up to the end of the study period. 2. Adverse effects. Clinical signs related to adverse effects are evaluated every 3 months 3. Resistance mutations if virologic failure 4. Clinical progression, evaluated every 3 months 5. Adherence to therapy, evaluated every 3 months | — |
Countries
Spain
Outcome results
None listed