Cost-effectiveness of different antiretroviral treatment in patients HIV naive

Phase 1

• Conditions: in patients HIV naive. Randomized clinical, not masked, trial comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 weeks; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-004820-24-ES
• Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-27
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1 adults (?18 years)

2 negative pregnancy test in women of childbearing age, and commitment to use of acceptable methods of contraception since at least 2 weeks prior to day 1 and even as at least 6 months after the last dose of the drug in the study.

3. stable HIV-1 infection clinically and who have not received prior antiretroviral therapy

4 to submit viral load HIV 100,000 copiasmL

5 have numbers of CD4 100 mm3

6 70mlmin Glomerular filtration

7 have a negative HLA B5701

8. patients should have given their informed written consent

9. in the opinion of the investigator, be able to follow the design of the Protocol visits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who have had prior virologic failure with any guideline antiretroviral
2 evidence of prior mutations against some of the study drugs
3. use of any other chronic anti-retroviral treatment has been introduced in the 6 months prior to the entry of the patient in the study
4. any contraindication to the drug study
5. any condition that does not allow to ensure the correct adherence to the study at the discretion of the doctor patient
6. uncontrolled pre-existing psychiatric illness
7. any current sign of active addiction or alcoholism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified