TMC114-TiDP29-C228: Study of antiviral activity of DRV in combination with low dose ritonavir in the treatment experienced HIV-1 infected childerns from 3 years to < 6 years of age.
- Registration Number
- CTRI/2009/091/000374
- Lead Sponsor
- Tibotec Pharmaceuticals, EastGate Village, Eastgate, Little Island, CO Cork, Ireland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Male or female children, aged between 3 years to less than 6 years at screening.
2. Subjects with a documented HIV 1 infection (by any of the local standard diagnostic methods, such as HIV PCR-DNA, ELISA or western blot (WB) test for HIV antibodies, etc.).
3. Body weight from 10 kg to <20 kg at screening.
4. Subjects currently on stable ART for at least 12 weeks, who need to change their ARV regimen because it is currently failing, with a viral load of > 1000 copies/mL.
5. Screening genotype resistance test results showing < 3 DRV resistance-associated mutations (RAMs)10.
Note: DRV RAMs are: V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V.
6. Parents or legal representative willing and able to give consent. Children will be informed about the trial as per description in PART II, Section 7.4.
7. Subjects can comply with the protocol requirements.
8. General medical condition, in the investigator?s opinion, does not interfere with the assessments and the completion of the trial.
1. Subjects with presence of any currently active conditions included in the listing of WHO Clinical Stage 4 (see Addendum 5: Revised WHO Clinical Staging of HIV/AIDS for Infants and Children) and subjects with presence of a non-HIV encephalopathy.
2. Use of disallowed concomitant therapy.
3. Administration of any ARV or non-ARV investigational medication or investigational vaccine within 30 days prior to screening, except for those medications where dose recommendations for children are available.
Note: DRV should not be used within 14 days following the use of tipranavir. A minimal 14 day washout period is required in which tipranavir must be either interrupted or substituted to an investigator selected PI regimen until the baseline visit (Day 1).
4. Life expectancy less than 6 months, according to the judgment of the investigator.
5. Co-enrollment in other clinical and/or cohort trials without written permission of the Sponsor.
6. Any active clinically significant disease (e.g., tuberculosis [TB], cardiac dysfunction, pancreatitis, acute viral infections) or findings during screening of medical history or physical examination that, in the investigator?s opinion, would compromise the subject?s safety or outcome of the trial.
7. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (DRV) or ritonavir.
Note: DRV is a sulphonamide-derivate. Subjects who previously experienced a sulfonamide allergy will be allowed to enter the trial. To date, no potential for cross sensitivity between drugs in the sulfonamide class and DRV has been identified in HIV 1 infected subjects participating in Phase II and Phase III trials (including the TMC114 C212 trial with HIV 1 infected subjects aged between 6 years and < 18 years).
8. Subjects with a laboratory abnormality greater than grade 2 as defined by age appropriate DAIDS grading scheme (grade 3 and 4 thrombocytopenia will be allowed).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method