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Table 1 Clinical trials of bNAbs in HIV-1 infected individuals with published results

From: Adeno-associated virus gene delivery of broadly neutralizing antibodies as prevention and therapy against HIV-1

Clinical trial

Trial design

Delivery

bNAb

Highest dose given (mg/kg)

HIV-1 infected individuals given highest dose

Dosing schedule

bNAb sensitivity prescreening

Viral response

References

NCT02018510

Suppression

Passive

3BNC117

30

8 viremic individuals

One dose

Some

Viral load was reduced by mean of 1.5 log10 copies/ml (range of 0.8–2.5), and significant for 28 days

[57]

NCT02446847

Maintenance

Passive

3BNC117

30

13 suppressed individuals

2 doses 3 weeks apart, or 4 doses 2 weeks apart; ART discontinued 2 days after first dose

All

2 infusions delayed rebound by mean of 6.7 weeks (range of 5–9) after ATI, and 4 infusions by mean of 9.9 weeks (range 3–19)

[58]

NCT01950325 (VRC 601)

Suppression

Passive

VRC01

40

8 viremic individuals

One dose

None

Amongst responders (6/8), viral load was reduced by 1.1–1.8 log10 copies/ml, and significant for 21 days

[55]

NCT02463227 (ACTG A5340)

Maintenance

Passive

VRC01

40

14 suppressed individuals

Dose 1 week before and 2 and 5 weeks after ART discontinuation

None

Rebound was delayed by 4 weeks (IQR 3–5) after ATI

[56]

NCT02471326 (NIH 15-I-0140)

Maintenance

Passive

VRC01

40

10 suppressed individuals

Dose 3 days before, 2 weeks after, and each subsequent month after ART discontinuation

None

Rebound was delayed by 5.6 weeks (IQR 4.1–5.6) after ATI

[56]

NCT02511990

Suppression

Passive

10-1074

30

13 viremic individuals

One dose

None

Amongst responders (11/13), viral load was reduced by mean of 1.5 log10 copies/ml (range 0.9–2.1), and significant for 27 days

[59]