Human Immunodeficiency Virus Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Randomised, Dose-Escalation Phase I Safety Study Of A Single Vaginal Administration Of P2G12 Antibody In Healthy Female Subjects
The purpose of this study is to assess the safety and tolerability of intravaginal administration of P2G12. 11 subjects will receive P2G12/placebo. Three subjects in Group 1 will receive up to 7mg of P2G12, or placebo. Three subjects in Group 2 will receive up to 14mg of P2G12, or placebo and five subjects in Group 3 will receive up to 28mg of P2G12, or placebo. A safety review will take place before subjects in Groups 2 and 3 receive study drug to determine if it is safe to proceed to the next dose of P2G12. Vaginal and cervical inspections will be performed to determine what effect, if any, the study drug has had on the site of administration. Adverse event data will be collected throughout the trial.
Status | Completed |
Enrollment | 11 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - A female adult subject aged between 18 and 50 years old. - They are in good health as determined by medical history, physical examination and clinical judgement before entering into the study. - Subjects must agree to abstain from vaginal sexual intercourse for 72 hours before and after dosing. - Subject must agree not to undertake any vaginal practices during study participation other than receptive intercourse with a male, or use of sanitary tampons during menses. Use of condoms without spermicidal agents is encouraged. - Confirmation from the subject's GP that there is nothing in the subject's medical history that would prevent the subject from participating in the study. Exclusion Criteria: - They have a known or suspected ongoing vaginal disease, malignancy or abnormality (including non-menstrual vaginal discharge) discovered at time of screening. - They have an abnormality, or non-menstrual discharge noted at screening colposcopy. - They present in the samples obtained at the screening visit: 1. positive results for HIV 1 or 2 antibody. 2. positive results for Hepatitis B sAg, anti-Hepatitis C antibody 3. positive syphilis serology 4. positive test for Neisseria gonorrhoea or Chlamydia trachomatis on urine or urethral swab sample 5. abnormal cervical smear cytology - A clinically significant amount of protein or haemoglobin in the urine sample, determined by urine dipstick. - They have received any form of immunosuppressive or immunomodulatory (e.g. vaccines) therapy in the past 6 months. - They are receiving any medications via vaginal route. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | Surrey Clinical Research Centre | Guildford | Surrey |
Lead Sponsor | Collaborator |
---|---|
University of Surrey | European Commission |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence, intensity and relationship to P2G12 administration of local and general adverse events (AEs) throughout the study period after drug administration. | 35 days. | Yes | |
Secondary | Changes in levels of P2G12 in blood and vaginal secretions as compared to baseline. | 35 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03516318 -
Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria
|
N/A | |
Completed |
NCT04653194 -
Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'
|
Phase 3 | |
Completed |
NCT01792570 -
DRV/r + RPV QD: Efficacy and Toxicity Reduction
|
Phase 3 | |
Active, not recruiting |
NCT04826562 -
Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
|
Phase 4 | |
Completed |
NCT04191967 -
Thermocoagulation for Treatment of Precancerous Cervical Lesions
|
N/A | |
Completed |
NCT02919306 -
Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults
|
Phase 1/Phase 2 | |
Completed |
NCT02812329 -
Intervention to Encourage HIV Testing and Counseling Among Adolescents
|
Phase 1 | |
Completed |
NCT02516930 -
A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China
|
N/A | |
Completed |
NCT02651376 -
Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients
|
Phase 1/Phase 2 | |
Recruiting |
NCT02392884 -
HIV Medication Adherence in Underserved Populations
|
N/A | |
Completed |
NCT01944371 -
Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT01778374 -
Mater-Bronx Rapid HIV Testing Project.
|
N/A | |
Completed |
NCT00914225 -
Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya
|
N/A | |
Completed |
NCT01490346 -
Tissue Drug Levels of HIV Medications
|
N/A | |
Completed |
NCT01076179 -
Kaletra in Combination With Antiretroviral Agents
|
N/A | |
Completed |
NCT01460433 -
Problems With Immune Recovery in the Gut Tissue
|
N/A | |
Completed |
NCT00317460 -
Buprenorphine and Integrated HIV Care
|
Phase 4 | |
Terminated |
NCT04240210 -
Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)
|
Phase 4 | |
Active, not recruiting |
NCT04704336 -
Integration of Hypertension Management Into HIV Care in Nigeria
|
N/A | |
Completed |
NCT03254277 -
3BNC117-LS First-in-Human Phase 1 Study
|
Phase 1 |