Study of Single IV Administration of P2G12

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomised phase I trial of a monoclonal antibody which neutralises HIV-1 (P2G12) to be given as a single intravenous infusion to healthy human volunteers to assess the safety and reactogenicity

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St George's, University of London
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Immunoglobulins

Criteria

Inclusion Criteria:

1. Volunteers aged between 18 and 45 years on the day of screening

2. Available for follow-up for the duration of the study

3. Willing and able to give written informed consent

4. At low risk of HIV and willing to remain so for the duration of the study defined as:

1. no history of injecting drug use in the previous ten years

2. no gonorrhoea or syphilis in the last six months

3. no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months

4. no unprotected anal intercourse in the last six months, outside a relationship with a regular partner known/presumed to be HIV negative

5. no unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner

5. Willing to undergo a HIV test

6. If sexually active, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; any IUCD/IUS; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first infusion until 4 months after, and willing to undergo urine pregnancy tests as per schedule

7. Agree to abstain from donating blood for three months after the end of their participation in the trial, or longer if necessary

8. Registered with a GP

9. Satisfactory response received from GP before randomisation

Exclusion Criteria:

1. Pregnant or lactating

2. Clinically relevant abnormality on history or examination including

1. history of grand-mal epilepsy

2. skin disorder might prevent insertion of IV line

3. liver disease with inadequate hepatic function (grade 1 or greater as described in appendix 3)

4. haematological, metabolic, gastrointestinal or cardio-pulmonary disorders

5. uncontrolled infection; immunodeficiency or use of immunosuppressives in preceding 3 months (including systemic steroids for longer than 14 days)

6. history of renal disease

7. history of autoimmune disease

3. Known hypersensitivity to any component of the infusion used in this trial, or have severe or multiple allergies to drugs or pharmaceutical agents

4. History of severe local or general reaction to vaccination which according to the investigators judgement might prevent participation

5. Receipt of blood products or immunoglobulin within 4 months of screening

6. Participation in another trial of a medicinal product, completed less than 30 days prior to enrolment

7. HIV 1/2 positive or indeterminate on screening

8. Positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment

9. A clinically significant amount of protein or blood in the urine

10. Grade 1 or above routine laboratory parameters (see appendix 3 for definitions). Hyperbilirubinemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia

11. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.

12. Unlikely to comply with protocol or the PI has any concerns about suitability of participation in the study