Cardiovascular Risk Factor Management in HIV Infection
Coronary Heart DiseaseDyslipidemia3 moreThere is growing evidence that antiretroviral therapy (ART) increases the risk of coronary heart disease (CHD) through metabolic side effects, such as dyslipidemia, insulin resistance, and type II diabetes. Prevalence of risk factors for CHD in HIV-infected individuals receiving ART in the Swiss HIV Cohort Study (SHCS) is high. This cluster randomised controlled trial is nested into the SHCS and will investigate whether physicians randomised to the routine provision of risk profiles from their patients receiving ART will improve the management of risk factors in HIV-infected patients compared to control physicians not routinely receiving such information. Risk profiles will be generated by the SHCS data center and provided to clinicians in all study centers.
Vicriviroc, a CCR5 Inhibitor, Added to an Optimized Antiretroviral Therapy for Previously Treated...
HIV InfectionsAcquired Immunodeficiency SyndromeThis is an international study of vicriviroc in 500 adult HIV-infected subjects who are failing standard antiretroviral therapy (ART). HIV must be of a certain type known as R5/X4-mixed tropic. Subjects allowed into the trial will be randomly assigned to treatment with vicriviroc 10 mg QD, vicriviroc 15 mg QD, or placebo in addition to other antiretrovirals (selected by the investigator to be optimal for the specific subject) containing at least 3 drugs, including a protease inhibitor (PI) boosted with at least 100 mg ritonavir QD. Subjects will be continued for up to 48 weeks of dosing.
Anti-HIV Immunoglobulin (HIVIG) in Prevention of Maternal-Fetal HIV Transmission (Pediatric ACTG...
Acquired Immunodeficiency SyndromeDisease Transmission2 moreTo determine if HIV hyperimmune globulin (HIVIG) given to HIV-positive pregnant women during the second and third trimester of pregnancy reduced the likelihood of maternal-fetal HIV transmission. Conducted in collaboration with the National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases. The trial was Pediatric ACTG Protocol 185.
Viral Activation Transfusion Study (VATS)
Acquired Immunodeficiency SyndromeBlood Transfusion2 moreThe purpose of the trial was to determine if transfusion of allogeneic blood to HIV-1 infected persons led to immune activation and consequent induction of HIV-1 or /or Cytomegalovirus (CMV) replication, and whether this adversely affected clinical prognosis.
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived...
HIV InfectionsTo evaluate the safety and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) using an accelerated dosage schedule; to evaluate duration of antibody response and its relationship to the dose and frequency of inoculation. Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV.
PHAT Life: Peer Versus Adult-Led HIV Prevention for Juvenile Offenders
HIV/AIDSThis application proposes a 2-arm randomized controlled trial comparing the impact of PHAT Life on 350 13-17 year-old offenders' risky sex, STI, substance use, and theoretical mediators when delivered by Youth Representatives (YR) vs. probation staff (PS). 100 facilitators will be recruited to deliver the intervention and participate in the research.
Evaluation of the Trans Women Connected Mobile App for Changes in Sexual Health-related Behavior...
HIV/AIDSHealth Knowledge3 moreThe study is a 2-arm cluster randomized controlled trial to be conducted with 450 trans women to assess the effectiveness of the Trans Women Connected mobile app. Those in the treatment arm will be provided with the Trans Women Connected app, to be downloaded to their own device, and asked to use it during a three month period. Those in the control arm will be asked to download a general health app and use it during the same three-month period. Participants will complete brief online surveys at baseline, immediately following the app-use period, and at 3- and 6-months following the conclusion of the app-use period. The baseline and follow-up assessments will collect data on demographic characteristics, measures related to our primary and secondary outcomes, and psychosocial measures. The primary outcome measures are self-reported STI/HIV testing and sex without a condom, with secondary measures including sexual risk behaviors, health care visits, perceived social support/connectedness, PrEP use, self-efficacy in negotiation/communication, and comfort with gender identity and appearance. In addition, process data, such as forum content, and usage data will be collected and analyzed.
Thermocoagulation for Treatment of Precancerous Cervical Lesions
Human Immunodeficiency VirusHPV Infection1 moreThe purpose of this study is to evaluate the safety, acceptability, and efficacy of Thermocoagulation for treatment of precancerous lesions among HIV-positive women in a screen-and-treat program in Western Kenya.
Same-Day Treatment With Genvoya vs. EFV/TDF/3TC
HIV/AIDSRandomized, open-label study comparing Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine (Genvoya) vs. Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine (EFV-TDF-3TC) in patients starting ART on the day of HIV diagnosis.
Assessing the Impact of an Educational HIV Prevention Intervention in Zambia
HIV/AIDSIn Zambia, 13% of the 15 to 49 year old population lives with HIV. The highest number of new HIV infections is among young people. To counter the spread of the disease, developmental and governmental actors are increasingly relying on educational behavior change tools. A particularly widely used tool, implemented by the German Development Corporation (henceforth, GIZ), is the so-called "Join-In-Circuit on AIDS, Love Sexuality" (JIC). The tool aims to improve a) HIV and sexual reproductive health knowledge, b) HIV testing uptake, and c) demand for health services. Previous research has investigated the direct effect of the JIC on knowledge about Sexually Transmitted Infections (STIs) as well as self-reported sexual behavior in Zimbabwe, and has found positive effects in both domains. The research project evaluates the JIC in Zambia. The study randomly assigns 170 participating schools to five different JIC treatment arms. The first two arms represent control schools. Here, no JIC will be implemented. The third arm implements the JIC among a random subset of students. The fourth arm implements the JIC among indegree central students. The fifth arm implements the JIC among edge betweeness central students. In each school, the JIC will be implemented in one pre-determined grade. Within each school at least 30 students will be selected. For larger schools, 20 percent of students in the selected grade are selected.