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GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV

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ClinicalTrials.gov Identifier: NCT03462810
Expanded Access Status : Available
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
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.

Condition or disease Intervention/treatment
Infection, Human Immunodeficiency Virus Drug: cabotegravir, CAB

Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • Drug: cabotegravir, CAB
    open label investigational product
    Other Names:
    • cabotegravir
    • CAB

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • HIV-infected patients will be eligible for treatment if ALL the following apply:

    • Male or female patients aged ≥ 18 yrs

NOTE: all female patients of reproductive potential should use every precaution to prevent pregnancy including either complete abstinence from intercourse from 2 weeks prior to administration of CAB, throughout receipt of CAB and for at least 52 weeks after discontinuation of CAB LA; or use of one of the following methods of highly reliable contraception:

  1. Contraceptive subdermal implant
  2. Intrauterine device or intrauterine system
  3. Combined estrogen and progestogen oral contraceptive
  4. Injectable progestogen
  5. Contraceptive vaginal ring
  6. Percutaneous contraceptive patches
  7. Male partner sterilisation with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation on male sterility can come from the site personnel's: review of subject's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner.

These allowed methods of contraception are only effective when used consistently/correctly and in accordance with the product label. The investigator is responsible for ensuring that patients understand how to properly use these methods of contraception.

  • Inability to construct a viable antiviral treatment regimen with commercially available medications;
  • Demonstrated need for a long acting, injectable antiretroviral including, but not limited to malabsorption or inability to achieve adequate drug levels via oral route. NOTE: Poor/incomplete adherence to oral meds is not a sufficient rationale for inclusion.
  • The patient/legal guardian or representative has given informed consent to treatment prior to administering CAB (in a manner consistent with all national requirements). The patient/legal guardian or representative has also given informed consent for the transmission of a copy of the anonymized adverse and serious adverse event (SAE) and pregnancy reports (in compliance with local regulatory authority requirements) to GSK and ViiV where allowable by local regulations, and to the country regulatory authority as required.

Exclusion Criteria:

  • Patients will not be eligible for treatment if ANY of the following apply:

    • 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)
    • ALT ≥ 3 times ULN and bilirubin ≥ 1.5 times ULN (with > 35% direct bilirubin)
    • Evidence for moderate to severe hepatic impairment, grade 3-4 liver fibrosis, or cirrhosis
    • Patients who are eligible for actively enrolling clinical trials involving CAB.
    • Significant coagulopathy precluding chronic IM dosing

NOTE: Patients should not be treated via the named patient/compassionate use program if they are eligible and/or able to participate in any of the Phase III clinical trials of CAB and the patient is suitable for participation in such clinical trials. In that instance (assuming consent is obtained) the patient should preferentially be enrolled into the ongoing clinical trial to allow detailed data collection. In accordance with national requirements patients should not be treated in the named patient/compassionate use program if they have responded to previous treatment with CAB in another clinical trial without review and prior approval by the VSLC.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462810


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
United States, California
GSK Investigational Site
San Francisco, California, United States, 94115
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30322
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27710
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Texas
GSK Investigational Site
Bellaire, Texas, United States, 77401
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T5H 3V9
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
France
GSK Investigational Site
Colombes, France, 92700
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Portugal
GSK Investigational Site
Setúbal, Portugal, 2910-446
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Switzerland
GSK Investigational Site
Zurich, Switzerland, CH-8063
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United Kingdom
GSK Investigational Site
Tooting, London, United Kingdom, SW17 0QT
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
ViiV Healthcare
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT03462810     History of Changes
Other Study ID Numbers: 205741
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by ViiV Healthcare:
cabotegravir, CAB
GSK1265744
Individual Patient Compassionate Use
HIV

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases