MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive).
The primary objectives of MTN-034 are to collect safety and adherence data for these two study products in an adolescent population and to provide important information regarding individual preference for the products. This trial enrolled 247 healthy, HIV-uninfected, adolescent females. Participants were randomized (1:1) to one of two study product application sequences: (a) daily FTC/TDF oral tablets for 24 weeks, followed by use of the dapivirine VR inserted monthly for 24 weeks; or (b) monthly dapivirine VR for 24 weeks, followed by daily FTC/TDF oral tablets for 24 weeks. After completing the randomized sequence of two study product use periods, participants then selected one of the study products (or neither) to use in the third and final 24 weeks of the trial. In total, participants will be followed up for approximately one and a half years. Participants could choose either or neither study product at any time during the third product use period.
Analysis of the data from a 2x2 crossover for a binary outcome, assuming null period effectsSection. ( 16.2-2x2crossoverbinary.sas ) This is an example of an analysis of the data from a 2 × 2 crossover trial with a binary outcome of failure/success. Fifty patients were randomized and the following results were observed. P142 double-blind, randomized, placebo-controlled, crossover trial to evaluate induction of clinical response in patients with moderate-severe crohn’s disease treated with rifaximin Previous Article P141 DEVELOPMENT OF A SELF-SCREENING TOOL FOR PERIANAL DISEASE IN PATIENTS WITH CROHN’S DISEASE: A PILOT STUDY. Hard Reset is an action-packed, single-player shooter for the PC. With over-the-top destruction, loads of enemies, great weapon variety and a beautifully realized cyberpunk setting, Hard Reset is sure to shake up the shooter scene. Tting of fibromyalgia treatment. Thus, we conducted a single-centre, proof-of-concept, randomized, placebo-controlled, crossover trial of ALA for the treatment of fibromyalgia. Twenty-seven participants were recruited, and 24 participants completed both treatment periods of the trial. The median maximal tolerated dose of ALA in this trial was 1663 mg/day. Treatment-emergent adverse events with.
The study was closed to accrual on May 28, 2020. Study follow-up is expected to complete in October 2021.
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Gilead Sciences, Inc.
Phase 2a, randomized, open label, crossover trial
MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive).
The primary objectives of MTN-034 are to collect safety and adherence data for these two study products in an adolescent population and to provide important information regarding individual preference for the products. This trial enrolled 247 healthy, HIV-uninfected, adolescent females. Participants were randomized (1:1) to one of two study product application sequences: (a) daily FTC/TDF oral tablets for 24 weeks, followed by use of the dapivirine VR inserted monthly for 24 weeks; or (b) monthly dapivirine VR for 24 weeks, followed by daily FTC/TDF oral tablets for 24 weeks. After completing the randomized sequence of two study product use periods, participants then selected one of the study products (or neither) to use in the third and final 24 weeks of the trial. In total, participants will be followed up for approximately one and a half years. Participants could choose either or neither study product at any time during the third product use period.
Crossover Trial Reset Tool
The study was closed to accrual on May 28, 2020. Study follow-up is expected to complete in October 2021.
Crossover Trial Rct
What Is Crossover Trial
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Gilead Sciences, Inc.
How To Extend Crossover Trial
Phase 2a, randomized, open label, crossover trial