Prospective, multi-center, one-arm pilot trial of Trizivir plus Tenofovir in adult HIV-infected antiretroviral-naive patients
Not Applicable
Completed
- Conditions
- HIV infectionInfections and Infestations
- Registration Number
- ISRCTN19938041
- Lead Sponsor
- Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
- Brief Summary
2008 results in https://pubmed.ncbi.nlm.nih.gov/18671476/ (added 23/10/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 93
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method <br> 1. CD4 changes, measured at baseline, week 12 and every 12 weeks thereafter up to the end of the study period.<br> 2. Adverse effects. Clinical signs related to adverse effects are evaluated every 3 months<br> 3. Resistance mutations if virologic failure<br> 4. Clinical progression, evaluated every 3 months<br> 5. Adherence to therapy, evaluated every 3 months<br>