About 53,928 results

Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

Jun 23rd, 2005 - Examine the ability of thymopentin (Timunox) to: Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.

SU5416 in Treating Patients With AIDS-Related Kaposi's Sarcoma

Aug 28th, 2014 - OBJECTIVES: I. Determine the antitumor effects of SU5416 in patients with chemotherapy refractory cutaneous AIDS-related Kaposi's sarcoma. II. Determine the safety and tolerability of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the safety of this regimen on HIV replication and immune parameters in these patients. V. Determ...

A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

May 24th, 2012 - Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potenti...

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

Feb 10th, 2013 - OBJECTIVES: I. Assess the toxicity associated with repeated vaccination with recombinant vaccinia virus expressing prostate-specific antigen (rV-PSA) in patients with metastatic adenocarcinoma of the prostate. II. Determine the optimal dose of rV-PSA given at monthly intervals based on cellular and hormonal immunity. III. Determine whether vaccination with rV-PSA is associated with anti-tumor a...

Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections

Before Daptomycin (Cubicin ®) approved by the U.S. FDA in 2003, There were large-scale clinical trials conducted that included more than 1,000 subjects and than Daptomycin got complicated skin and soft tissue infections (CSSSI) indication. After 2004, Daptomycin got new indications about bacteremia and endocarditis due to success outcomes in the clinical trial which included infected in blood f...

Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

Jun 24th, 2013 - Although patient reminder/recall systems have been shown to be effective at improving vaccination coverage levels for infants and younger children, little is known about the effectiveness of such systems for increasing immunization rates in adolescent populations. The process of reminder/recall in adolescents, and vaccination of adolescents overall, presents particular challenges. Adolescents a...

Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis

Jun 9th, 2011 - Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multi-center, prospective, open-label, single-arm study of doripenem in the treatment of complicated lower urinary tract infection or pyelonephritis in adults. Patients are hospitalized, but subsequently, patients may treated as outpatient or through home-based therapy at the discretion of the investigators...

Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus

Dec 27th, 2010 - Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

Sep 5th, 2017 - A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

Jul 5th, 2018 - This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrho...

Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children

Oct 7th, 2015 - RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age in the world. RSV illness can range from mild upper respiratory tract illness (URI) to severe LRI, including bronchiolitis and pneumonia. Severe RSV disease in infancy may also predispose children to develop reactive airway disease during childhood. The purpose of thi...

Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

Jun 24th, 2018 - Eligible participants, with both a history of recurrent BV and a current episode of BV, will receive a seven-day course of oral metronidazole. Participants who are successfully treated for their BV, and continue to be eligible, will be randomly assigned to receive either 1% SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks. The primary endpoint will be determined...

Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention

Sep 11th, 2014 - Scientific Context: High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. Th...

Multi-Center Study of New Medications to Treat Vaginal Infections

Jun 28th, 2018 - The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole gel in the treatment of vaginal infections

Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive

Jun 21st, 2012 - Compare the efficacy and safety of viramidine 600 mg twice a day (BID) versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2a to treatment-naive patients with chronic hepatitis C (CHC)

Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery

Jun 25th, 2018 - Subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo after cataract surgery. They will be followed for one month to determine if there is a statistically significant difference in the incidence of endophthalmitis.

Safety and Acceptability of a Vaginal Microbicide

Mar 26th, 2012 - While the male condom is effective in preventing sexual transmission of HIV, its use is hampered by deeply rooted cultural and social barriers. About half of all HIV infections worldwide occur in women, yet the only available female-controlled method of HIV prevention is the female condom. Alternative prevention tools, such as vaginal microbicides, are urgently needed to slow the rapid spread o...

Nasal Ocular Reflexes Contribute to Eye Symptoms

Sep 4th, 2013 - Symptoms of conjunctivitis (tearing, redness and itching) frequently occur in patients with allergic rhinitis. The pathophysiology underlying these symptoms remains to be elucidated. The symptoms probably arise via a combination of mechanisms including direct contact of natural pollen with the conjunctiva and reflex mechanisms originating in the nose. Pollen exposure can result from direct hand...

A Phase 1 Safety and PK Study of IV TP-271

Sep 25th, 2018 - Up to 5 cohorts of 8 subjects each (up to a total of 40 subjects) will be enrolled. The 8 subjects within each cohort will be randomized 6:2 to receive multiple IV doses of TP-271 or placebo. Study drug will be administered IV once daily on the morning of Days 1 through 7 following an overnight fast (minimum 8 hours). The planned doses for study drug for Cohorts A - E are 0.5 mg/kg TP-271 or pl...

Effect of the Atazanavir (ATV) 150L Mutation on Subsequent Treatment Response in HIV Infected Subjects

Apr 12th, 2011 - This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.