Track topics on Twitter Track topics that are important to you
This study will evaluate the safety and efficacy of the long-acting injectable agent cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in HIV-uninfected women.
The purpose of this study is to evaluate the safety and efficacy of the long-acting injectable integrase inhibitor cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in a population of sexually active HIV-uninfected women at risk for HIV.
This study will take place in three steps. Participants will be randomly assigned to one of two arms:
Step 1: Participants will receive daily oral CAB and TDF/FTC placebo for 5 weeks.
Step 2: Participants will receive injections of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily TDF/FTC placebo beginning at Week 5.
Step 1: Participants will receive daily TDF/FTC and oral CAB placebo for 5 weeks.
Step 2: Participants will receive daily TDF/FTC and intramuscular (IM) placebo injections at two time points 4 weeks apart and every 8 weeks thereafter beginning at Week 5.
Step 2 will continue until the last enrolled participant reaches approximately 76 weeks on Step 2 (Week 81 for the last enrolled participant).
In Step 3, all participants (Arms A and B) will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection.
At the end of Step 3, all participants will then transition to locally available HIV prevention services, including services for PrEP, if available.
Study visits will occur at Day 0 and at Weeks 2 and 4 during Step 1. During Step 2, participants will attend up to 24 visits, depending on when they enroll in the study. Study visits will occur every 12 weeks during Step 3. Study visits may include physical examinations; blood, urine, and vaginal swab collection; and risk reduction and adherence counseling.
Oral CAB, Oral TDF/FTC, Placebo for oral CAB, Placebo for oral TDF/FTC, CAB LA, Placebo for CAB LA
Not yet recruiting
National Institute of Allergy and Infectious Diseases (NIAID)
Published on BioPortfolio: 2017-05-24T16:38:21-0400
The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who wer...
To evaluate the safety and tolerability of ascending single (Part A) and ascending multiple (Part B) doses of AMG 986 in healthy subjects, who received AMG 986 by constant intravenous (IV)...
Objectives: This study will test the ability of an epidermal growth factor receptor (EGFR) inhibitor (erlotinib) to reduce the incidence of oral cancer in the high-risk setting of oral ...
The main purpose of this study is to assess the efficacy of melatonin oral gel compared to placebo in the prevention and treatment of oral mucositis in patients with head and neck cancer u...
The purpose of this study is to expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin. Also the purpose ...
To compare oral voriconazole versus placebo in addition to topical antifungals in the treatment of filamentous fungal keratitis.
Only two, small placebo-controlled trials on peanut- oral immunotherapy (OIT) have been published.
The effect of combined oral contraceptives (COC) on female sexuality has long been a matter of discussion, but placebo-controlled studies are lacking. Thus, the aim of the present study was to investi...
Response to letter to the editor re: Goldblatt LI, Adams WR, Spolnik KJ, Deardorf KA, Parks ET. Chronic fibrosing osteomyelitis of the jaws: An important cause of recalcitrant facial pain. A clinicopathologic study of 331 cases in 227 patients. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017;124:403-412.
The presence of gram-negative bacteria in the oral cavity is an undesirable occurrence in patients undergoing chemotherapy. Our aim was to investigate the antibacterial effect of 0.12% chlorhexidine m...
A branch of dentistry dealing with diseases of the oral and paraoral structures and the oral management of systemic diseases. (Hall, What is Oral Medicine, Anyway? Clinical Update: National Naval Dental Center, March 1991, p7-8)
The practice of personal hygiene of the mouth. It includes the maintenance of oral cleanliness, tissue tone, and general preservation of oral health.
An offensive, foul breath odor resulting from a variety of causes such as poor oral hygiene, dental or oral infections, or the ingestion of certain foods.
Disorders of the mouth attendant upon non-oral disease or injury.
A dental specialty concerned with the diagnosis and surgical treatment of disease, injuries, and defects of the human oral and maxillofacial region.
Reverse transcriptase (RT) is an enzyme used to generate complementary DNA (cDNA) from an RNA template, a process termed reverse transcription. It is mainly associated with retroviruses. RT inhibitors are widely used as antiretroviral drugs. RT activitie...
Human Immuno Deficiency Virus (HIV)
Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...