
Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS
Acquired Immunodeficiency SyndromeThe aim of the Post Marketing Study (PMS) is to evaluate the efficacy and safety profile of nevirapine in the management of the HIV/AIDS in an open environment.

Determination of Optimum Age for DXA Screening for Osteoporosis in HIV - The Probono 1 Study
OsteoporosisFractures1 moreThe purpose of this study is to determine the bone mineral density in male and female patients with HIV infection according to age groups. This will enable a practical approach to screening for osteoporosis and the management and prevention of fragility fractures in people with HIV. In addition, all risk factors commonly associated with fragility fractures and osteoporosis are collected, as is HIV drug history. Hence, as secondary outcomes, the associations with reduced bone mineral density can be ascertained.

A Pilot Study on Raltegravir, Tenofovir and Emtricitabine for Peri-exposure Prophylaxis for HIV...
InfectionHIVThis will be a pilot, open label study involving 65 participants. All participants will be followed until seroconversion or until the last enrolled participant completes one year of follow-up, whichever happens first. Participant study number will be given at the screening visit, prior to inclusion in the study. The chosen intervention and study regimen are based on the dynamics of viral infection and the pharmacokinetics of the study drugs. In order to inhibit reverse transcription nucleoside and nucleotide analogues need to be phosphorylated intracellularly. On the other hand, available data indicate that it takes approximately 10 hours between exposure and HIV viral integration, offering a window of opportunity for Raltegravir to block integration and thus prevent infection, given that this drug does not need to be metabolized to exert its effect. The intervention will be maintained for 4 weeks following exposure, in accordance with Brazilian and CDC guidelines for PEP.

Body Image in Youth With HIV
Human Immunodeficiency VirusHIVThis is an observational study that seeks to gather information about perceptions of body image through the use of a one-time questionnaire completed by participants at the time of study enrollment. Effective management of Human Acquired Immune Deficiency Syndrome (AIDS) caused by the Human Immunodeficiency Virus (HIV) has become possible through the use of Highly Active Antiretroviral Treatment (HAART). As a result of more successful treatment options, HIV/AIDS has transitioned from a terminal illness to one which is treated as a chronic condition. One particular group that has been impacted tremendously by HIV in the United States is the adolescent population. As youth are living longer with HIV/AIDS, clinicians and researchers are beginning to examine ways in which the disease can affect one's physical health, mental health, and other psychosocial factors. Research emerging involving adults with HIV/AIDS has suggested that increased attention to and negative views of one's body image may be found at a higher rate in this group. To our knowledge, very few studies have examined this relationship in adolescents with HIV.

Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals
InfluenzaHuman1 moreInvestigators in the Division of Infectious Diseases are carrying out a study to determine if human immunodeficiency virus (HIV)-seropositive patients receiving the Seasonal Influenza vaccination develop an adequate antibody response. The study group will consist of individuals seen in the Infectious Diseases Clinic who are HIV-seropositive and receive the Seasonal Influenza vaccine.

Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng
Human Immunodeficiency VirusThis trial will assess the potential impact of a vaginal ring on condom use by comparing the performance (total clinical failure, clinical slippage, and clinical breakage) of a standard male lubricated latex condom when the female partner is wearing the vaginal ring and when the female partner is not wearing the vaginal ring.

Relationship of Tenofovir With HIV-1 Suppression in ex Vivo Tissue in Adolescents
Human Immunodeficiency VirusMicrobicides are topical medicines that can prevent infection by Human Immunodeficiency Virus (HIV). Microbicide medicine has yet to be studied in adolescents, a key group that is becoming infected with HIV all over the world. From past research, we know that at different ages people experience age-related changes in their bodies that can cause differences in how they process medications. In this study, gut tissue samples (or gut biopsies) from 12 HIV-negative volunteers will be collected. These pieces of tissue will be infected with HIV in the laboratory to develop a model that can be used to test certain drugs against the HIV infection. We can use this tissue to test a drug called tenofovir against HIV infection. We will determine whether this drug can decrease HIV infection in the gut biopsies. In this study, we will also measure HIV levels and the levels of tenofovir in gut and blood samples in 12 people who are already taking this drug. This information can determine whether levels of drug found in the gut can protect it from HIV. The results can be compared to other age groups of adolescents and adults. Subjects will undergo a common procedure called a lower endoscopy (this can be a colonoscopy or a flexible sigmoidoscopy) to obtain gut biopsy samples. The central hypothesis is that tissue drug profiles of tenofovir (TFV) and its active component, tenofovir disoproxil fumarate (TDF), and tissue infectibility vary between younger (10-14 years old) versus older adolescents (18-21 years old), and that both differ from adults (>21 years). Specifically, younger HIV positive adolescents will have lower levels of tissue tenofovir compared to older HIV positive adolescents and adults in an age-dependent manner. Additionally, biopsies from younger HIV negative adolescents will have: 1) higher rates of infection compared to biopsies from older HIV negative adolescents infected with a lower dose of virus; and 2) lower percent suppression of tissue infectivity compared to biopsies from older HIV negative adolescents using low dose tenofovir.

Special Investigation of Kaletra in Pregnant Women
Human Immunodeficiency VirusThis non-interventional, post-marketing observational study was conducted to obtain safety data from the use of lopinavir/ritonavir (Kaletra), in clinical practice, in pregnant women and their children in Japan.

PENTA Fosamprenavir Study
InfectionHuman Immunodeficiency VirusTwice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated for the treatment of HIV-infected adults, adolescents and children of 6 years of age and above for use in combination with other anti-HIV medicines. Safety data from two GlaxoSmithKline (GSK) clinical trials (APV29005 - involving twice-daily doses of FPV with or without RTV and APV20003 - with once daily dosing of FPV/RTV among 2-18 year olds) indicated that gastrointestinal events were the most commonly reported AEs, but that the majority of events were mild and of short duration. Treatment emergent grade 3 / 4 neutropenia was reported in 20% of children in the APV20003 trial; and neutropenia was identified as a potential safety concern by the European Medicines Agency (EMEA). The objectives of this study were to conduct an observational cohort study of the usage and safety of FPV/RTV in children and adolescents (aged 6 ≤ 18 years) with HIV infection in several European HIV paediatric cohorts. Data will be collected for 3 years (2008, 2009 and 2010).

Injecting Drug Use Community Intervention Trial
HIVHepatitis C3 moreThe purpose of this study is to reduce the HIV/HCV incidence among the clients attending community-based methadone maintenance treatment (MMT) , and to prevent the secondary sexual transmission from HIV+ clients to their spouse and sex partners, through intensified comprehensive intervention.