Safety Clinical Trial
Official title:
MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Prototype Vaginal Films
This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, Kenya, South Africa, and Zimbabwe. The study will assess the acceptability and safety of two placebo vaginal films. The placebo films do not contain any active medication, are the same size, but differ by shape (square versus rounded corners). Participants will be randomly assigned to one of the two films and asked to use (self-insert) the assigned film two times (approximately one month apart). Participants will be asked to refrain from sexual activity during the first month of use and may resume usual sexual activity during the second month of use. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples. The study involves a total of 10 visits/contacts, including in person visits and telephone calls over approximately 9 weeks. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in depth interviews to further assess acceptability, attitudes, and experiences with film use to gauge interest in the future use of vaginal films as a HIV prevention option.
The goal of this randomized, clinical trial is to compare two placebo vaginal films in HIV seronegative adult (18-45 years old) persons assigned female sex at birth who are at low risk of acquiring HIV infection, and sexual partners of evaluable participants. Participants will be recruited from five sites, one in the US and four is sub-Saharan Africa. Approximately 100 participants will be randomized (1:1), stratified by site, to insert either placebo vaginal film A or placebo vaginal film B, which differ only by shape, once monthly for two months. Participants will be asked to refrain from sexual activity during the first month of use and may resume usual sexual activity during the second month of use after insertion of the second film which will be the same film they were assigned to use during the first month. Differences in safety, acceptability, usability, social harms and benefits, and vaginal microenvironment between the two films and the two study phases (i.e., with and without sexual abstinence requirement) will be assessed. In addition, both participants and approximately 30 sexual partners of evaluable participants will be asked to take part in in depth interviews to further assess acceptability, attitudes, and experiences with film use to gauge interest in the future use of vaginal films as a HIV prevention option. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05073744 -
Nalbuphine Versus Morphine for Perioperative Tumor Ablation
|
Phase 4 | |
Completed |
NCT03969641 -
Safety of RIV4 Versus IIV4 in Pregnant Women
|
Phase 4 | |
Completed |
NCT05592951 -
Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
|
N/A | |
Completed |
NCT04693429 -
Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+
|
Phase 1 | |
Completed |
NCT01636024 -
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594
|
Phase 1 | |
Completed |
NCT01415102 -
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
|
Phase 1 | |
Completed |
NCT01243502 -
A Study to Assess the Pharmacokinetics, Safety and Tolerability of CT327 in Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT06072170 -
Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience
|
Phase 1 | |
Completed |
NCT05076253 -
Efficacy of Ivermectin in COVID-19
|
Phase 1/Phase 2 | |
Recruiting |
NCT06060379 -
Giochiamo 626 - Gaming for Health and Safety in Workplaces
|
N/A | |
Recruiting |
NCT05298800 -
Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23
|
Phase 4 | |
Completed |
NCT05188638 -
Safety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects
|
Phase 1 | |
Completed |
NCT05145621 -
Oral Bio-equivalence Study
|
Phase 1 | |
Recruiting |
NCT05580159 -
New Generation mRNA Booster Vaccine Against Emerging VOCs
|
Phase 3 | |
Not yet recruiting |
NCT04596956 -
Safety and Efficacy of Sodium Bicarbonate Ringer Injection
|
Phase 4 | |
Completed |
NCT03033329 -
Single Dose Escalation and Multiple Dose Escalation Trial of an Intravenous Formulation of MRX-4
|
Phase 1 | |
Terminated |
NCT01929811 -
NeoMET Study in Neoadjuvant Treatment of Breast Cancer
|
Phase 2 | |
Completed |
NCT01193335 -
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
|
Phase 4 | |
Completed |
NCT03300466 -
A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
|
N/A | |
Active, not recruiting |
NCT05686161 -
mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs
|
Phase 3 |