TABLE 1.
Case type | Case description | Infection description | Classification |
No. of cases | |
---|---|---|---|---|---|
Previous report | Current report | ||||
A | Baseline infection | HIV positive at study enrollment | A1–A4 | 4 | |
B | No recent CAB administration | No CAB administration in the 6 mo before the 1st HIV-positive visit | B1–B5 | B6–B16 | 16 |
C | Oral-phase infection | Infected during the 5-wk oral CAB lead-in phase | C1–C3 | 3 | |
D | Infected despite on-time injections | Infected <6 mo after the last injection with on-time injections | D1–D4b | D5–D6 | 6 |
DX | Delayed injection | Infected <6 mo after the last injection with at least 1 delayed injection (>70 days after the last injection) | DX1–DX3 | 3 | |
BR | CAB restarted after infection | No CAB administration in the 6 mo before the 1st HIV-positive visit; CAB restarted at or after the 1st HIV-positive visit | BR1–BR2 | 2 | |
Total no. of cases | 16 | 18 | 34 |
The approach used to classify infections in the cabotegravir (CAB) arm of HPTN 083 is shown. Sixteen cases were described in a previous report (3); 18 additional cases are included in this report. HIV testing performed at study sites and the HPTN Laboratory Center was used to determine HIV infection status and identify the first HIV-positive visit. Injections were classified as delayed if they were administered >2 weeks after the planned injection date (>44 days after the 1st injection or >70 days after subsequent injections).
One case that was classified as a D case in the previous report had a single late injection (D1) (75 days after the previous injection); that case would have been classified as a DX case according to the updated classification system used in this report.