GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorViiV Healthcare
About this trial
The goal of this compassionate use program is to provide a mechanism to supply Cabotegravir, CAB on an individual named patient basis for treatment of individuals who have no available treatment alternatives and/or limited treatment options (e.g., who are unable to participate in the Phase III clinical studies or do not qualify), and are in need of new drugs to construct an effective antiviral regimen and may require the use of parenterally administered drug given underlying medical conditions. You can access ViiV's Policy on Compassionate via https://us.viivhealthcare.com/media/124424/viivs-external-policy-on-cup\_final-version\_23feb2017.pdf.
Eligibility criteria
Qualifiers
Male or female patients aged ≥ 18 yrs
Contraceptive subdermal implant
Intrauterine device or intrauterine system
Combined estrogen and progestogen oral contraceptive
Disqualifiers
Patient has estimated creatinine clearance <50 mL/min via Cockcroft-Gault method;
Females who are pregnant or women who are breastfeeding, or plan to become pregnant or breastfeed during treatment.
Patients who have had known or suspected allergic reaction or hypersensitivity reactions to integrase inhibitors;
Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN)
Trial design
Treatments tested in this trial
- cabotegravir, CAB
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov