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

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.