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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03462810
Expanded Access Status : Available
First Posted : March 13, 2018
Last Update Posted : May 21, 2021
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

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

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT03462810

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Contact: US GSK Clinical Trials Call Center 877-379-3718

Sponsors and Collaborators
ViiV Healthcare
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Study Director: GSK Clinical Trials ViiV Healthcare
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Responsible Party: ViiV Healthcare Identifier: NCT03462810    
Other Study ID Numbers: 205741
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: October 2020
Keywords provided by ViiV Healthcare:
cabotegravir, CAB
Individual Patient Compassionate Use
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Genital Diseases
Urogenital Diseases
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents