Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04692077
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2020-12-22
Brief Title:
Safety Tolerability and Acceptability of Long-Acting Cabotegravir CAB LA for the Prevention of HIV Among Adolescent Males - A Sub-study of HPTN 083
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Safety Tolerability and Acceptability of Long-Acting Cabotegravir CAB LA for the Prevention of HIV Among Adolescent Males - A Sub-study of HPTN 083
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will establish the minimum safety tolerability and acceptability data needed to support the use of cabotegravir long-acting injection CAB LA in an adolescent population potentially transforming the field of HIV prevention for young people
Detailed Description:
The purpose of this study is to establish the minimum safety tolerability and acceptability data needed to support the use of cabotegravir long-acting injection CAB LA in an adolescent population potentially transforming the field of HIV prevention for young people
This study will enroll healthy HIV-uninfected adolescents assigned male at birth including men who have sex with men MSM transgender women TGW and gender non-conforming people The total participant commitment for the entire study is approximately 15 years
This study will take place in three steps In Step 1 participants will receive daily oral CAB tablets for 5 weeks In Step 2 participants will receive a series of five intramuscular IM injections of CAB LA administered at 8-week intervals after a 4-week loading dose injections at Weeks 5 9 17 25 33 A safety visit will follow each injection to ascertain safety data including injection site reactions In Step 3 all participants who have received at least one injection will be followed quarterly every 3 months for 48 weeks after their last injection Participants will receive oral TDFFTC for daily use for 48 weeks or may be provided the opportunity to enroll in a local open label study of CAB if available
Participants will attend about 18 study visits throughout the study Visits may include physical examinations blood collection urine collection rectal and oral pharyngeal swab collection risk reduction and adherence counseling and behavioral or acceptability assessments
This study will enroll healthy HIV-uninfected adolescents assigned male at birth including men who have sex with men MSM transgender women TGW and gender non-conforming people The total participant commitment for the entire study is approximately 15 years
This study will take place in three steps In Step 1 participants will receive daily oral CAB tablets for 5 weeks In Step 2 participants will receive a series of five intramuscular IM injections of CAB LA administered at 8-week intervals after a 4-week loading dose injections at Weeks 5 9 17 25 33 A safety visit will follow each injection to ascertain safety data including injection site reactions In Step 3 all participants who have received at least one injection will be followed quarterly every 3 months for 48 weeks after their last injection Participants will receive oral TDFFTC for daily use for 48 weeks or may be provided the opportunity to enroll in a local open label study of CAB if available
Participants will attend about 18 study visits throughout the study Visits may include physical examinations blood collection urine collection rectal and oral pharyngeal swab collection risk reduction and adherence counseling and behavioral or acceptability assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 38654 | REGISTRY | DAIDS ES | None |