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This study will assess the pharmacokinetics (PK), safety, and tolerability of CAB ULA administered every 4 months (Q4M) following administration of CAB LA every 2 months (Q2M), in healthy adult volunteers.
The participants in the study will receive CAB LA in the CAB LA phase and CAB ULA in the CAB ULA phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAB Group | Experimental | Participants will receive the CAB LA Q2M regimen up to Month 9 then will receive the CAB ULA Q4M regimen up to Month 23. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAB LA | Drug | CAB LA injection will be administered |
| |
| CAB ULA |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of CAB at the end of the CAB LA phase compared to plasma concentration of CAB at the end of the CAB ULA phase | At Month 23 compared to Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of CAB at each assessment timepoint following CAB ULA injections | Up to Month 23 | |
| Number of participants with adverse events (AEs) (including Injection Site Reactions [ISRs]) as per severity | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening. |
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Inclusion Criteria:
Healthcare staff will be eligible for inclusion in this study if:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | 36608 | United States | ||
| GSK Investigational Site |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
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| Drug |
CAB ULA injection will be administered |
|
| Up to Month 32 |
| Number of participants with laboratory abnormalities | Up to Month 32 |
| Number of participants with changes in laboratory parameters over time | Up to Month 32 |
| Number of participants with ISRs by grade | Severity of ISRs is graded according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening | Up to Month 32 |
| Duration (Days) of ISRs by grade | Severity of ISRs is graded according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening. | Up to Month 32 |
| Coral Gables |
| Florida |
| 33134 |
| United States |
| GSK Investigational Site | Oak Brook | Illinois | 60532 | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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