A phase IV clinical trial to assess the safety and tolerability of Darunavir 800mg tablets once daily in HIV 1 infectio
- Conditions
- Health Condition 1: B20- Human immunodeficiency virus [HIV]disease
- Registration Number
- CTRI/2018/05/014117
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Audio consent and a written signed dated informed consent from subjects and/or legally acceptable representative
2. Either gender with age 18 years and above
3. Subjects with human immunodeficiency virus (HIV -1) infection who are treatment-experienced adult patients with no Darunavir resistance associated substitutions
(V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V)
1. Known hypersensitivity to Darunavir Ethanolate or Ritonavir or any of its components or other anti-retroviral agents given concomitantly
2. Subjects with sulfa allergy
3. Pregnancy or breastfeeding
4. Severe Hepatic Impairment Child Pugh Class C
5. Concomitant use of drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index)
6. Subject unsuitable to participate in the study as per the discretion of investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess safety and tolerability of Darunavir Ethanolate 800mg tablets once daily co-administered with Ritonavir 100mg tablets once daily and other anti-retroviral agents in adult subjects with HIV-1 infection.Timepoint: Visit 1- Screening visit <br/ ><br>Visit 2- Baseline Visit <br/ ><br>Visit 3- Week 12 <br/ ><br>Visit 4- Week 24
- Secondary Outcome Measures
Name Time Method oneTimepoint: None