View clinical trials related to HIV.
Filter by:HIV risk among female entertainment and sex workers (FESW) remains high and use of amphetamine-type stimulants (ATS) significantly increases this risk. We designed a cluster randomized stepped wedge trial: The Cambodia Integrated HIV and Drug Prevention Implementation [CIPI) study. The CIPI study is embedded within the SMARTgirl HIV prevention program. The CIPI study aimed to recruit FESW from 10 provinces, assessing HIV risk exposures including ATS use. The CIPI study then tested sequentially delivered, behavioral interventions targeting ATS use. The trial combines a 12-week Conditional Cash Transfer (CCT) intervention with four-weeks of cognitive-behavioral group aftercare (AC) among FESW who use ATS. The primary goal of the CIPI study is to reduce ATS use and unprotected sex among FESW. The CCT+AC intervention is being implemented in ten provinces where order of delivery was randomized. Outcome assessments (OEs) including biomarkers and self-reported measures of recent sexual and ATS use behaviors are conducted prior to implementation, and at three 6-month intervals after completion. All women who are ATS negative at 6-months, including those who have completed the CCT+AC intervention are eligible to participate in a micro-enterprise (ME) opportunity. Consultation with multiple groups and stakeholders on implementation factors facilitated acceptance and operationalization of the trial. Statistical power and sample size calculations were based on expected changes in ATS use and unprotected sex at the population level as well as within-subjects. Dissemination of process indicators during the multi-year trial is carried out through annual in-country Stakeholder Meetings. Provincial 'Close-Out' forums are held at the conclusion of data collection in each province. When analysis is completed, dissemination meetings will be held in Cambodia with stakeholders, including community-based discussions sessions, policy briefs, and results published and presented in the HIV prevention scientific journals and conferences. CIPI is the first trial of an intervention to reduce ATS use and HIV risk among FESW in Cambodia. Results will inform both CCT+AC implementation in low and middle-income countries and programs designed to reach FESW.
The purpose of the clinical trial is to evaluate the safety and immunogenicity in female volunteers of EN41-UGR7C vaccine candidate adjuvanted with Alum using IM administration. The objective of the immunisation is to induce mucosal and systemic binding and neutralizing antibodies against HIV in order to block the virus on the mucosal surface and neutralise the viral particles that may eventually succeed in crossing the mucosal barrier. This is a Phase 1 exploratory study. EN41-UGR7C will be administered for the first time in humans. Volunteers who are vaccinated with EN41-UGR7C may develop an immune response against HIV, but its ability to induce meaningful protection against HIV will not be known before Phase 3 efficacy trials are completed, as correlates of protection against HIV are not yet clearly defined. Consequently, there is no direct benefit to volunteers. They will be reimbursed for their time and travel.
During the formative research phase, investigators will undertake formative studies to locate, understand, and characterize high-risk social networks of African American MSM in the community; gain community participation, involvement, and input; and undertake interviews with key informants and community members to gain information needed to pilot test study recruitment procedures, measures, and intervention content. During a 4-year main outcome trial phase, the investigators will enroll 24 separate sociocentric ("bounded") social networks composed predominantly of Black MSM. Each sociocentric network will consist of the ring of friends surrounding an initial high-risk index as well as all friends surrounding persons in this second ring and then friends surrounding a successive third snowball ring of enrollees. Each 3-ring sociocentric network is expected to consist of approximately 40 unique members (n=24 networks, each with 40 members = approximately 960 individual participants). All participants will be assessed at baseline to measure sexual practices, substance use, and other risk characteristics over the past 3 months; asked to provide biological specimens to be tested for HIV and other sexually transmitted diseases (STDs); and counseled in HIV/STD risk reduction. STDs will be treated and those with HIV will be referred for treatment. The investigators will identify the individuals in intervention condition networks with the greatest number of reciprocal interconnections and the most favorable sociometric standing in the network. These individuals--expected to constitute approximately 20% of the sociocentric network and designated as network leaders--will be recruited to attend a 9-session program that provides training and guidance in how to deliver on-going, theoretically-based, and culturally tailored risk reduction advice and counseling to other members within the same network. Six and 18 months following the intervention, all participants will be reassessed on risk behavior and STD/HIV laboratory measures as well as measures of intervention exposure, with positive STD and HIV cases respectively treated or referred to care at each assessment point. Outcome analyses will test whether there is greater reduction in high-risk sexual practices, substance use associated with risky sex, and HIV/STD incidence within social networks in the intervention condition. The primary trial endpoints are reductions in prevalence and frequency of unprotected anal intercourse with nonexclusive partners, increased condom use, and lower incidence on a composite biological measure of new HIV/STD disease during the followup period.
Formative Research Phase (Months 1-6) The investigators will undertake qualitative formative studies to: (1) identify barriers to highly active antiretroviral therapy (HAART) and strategies currently used to engage PLH in care; (2) identify access points and ways to reach a diversity of PLH social networks; (3) gain an understanding of PLH views, motivations, barriers, and facilitators of care entry, maintenance, and adherence; (4) examine the structure and segments of the PLH community in St. Petersburg; and (5) elicit input from members of the PLH community and its stakeholders concerning the planned network recruitment, assessment, and intervention procedures and content. The investigators will refine protocols used in their intervention pilot study based on findings of the formative research phase. Main Trial Phase (Months 7-60) Overview of the main intervention outcome trial's experimental design. The main trial is a two-arm randomized outcome study. A total of 32 sociocentric social networks of PLH will be recruited by first identifying initial seeds—always PLH who are either out-of-care or treatment nonadherent—in multiple access points that were identified in the formative phase. The investigators will then enroll three rings of HIV+ friends outward beginning with each seed. Each sociocentric network is expected to consist of approximately 16 to 18 individuals (expected n=32x18=576 participants). This estimate is based on the size and density of participants' personal networks observed in our pilot studies. Each network member will be assessed at baseline using measures to be described shortly and will receive individual motivational counseling in care and adherence. This session will "prime" participants to an understanding about the availability, accessibility, and benefits of care. Members of the 16 PLH networks randomized to the experimental condition will then receive the network intervention. Cadres of empirically identified influence leaders within each network will be identified, trained, and engaged to reinforce network member engagement and adherence. At 6- and 12-month followup points, assessment data will again be collected to determine intervention impact on the primary and secondary outcomes.
The purpose of this protocol is to learn more about impulsive decision making in people who use methamphetamines. The investigators would like to know if a medication called naltrexone changes how people make decisions. The investigators would also like to know whether changes in decision making can be observed by MRI (magnetic resonance imaging). The research is conducted in Portland, OR.
The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.
Gay Poz Sex (GPS) is a peer-facilitated holistic sexual health program for gay and bisexual HIV-positive men. Groups of five to eight men attend eight weekly sessions which cover basic sexual health information, review the current legal context surrounding HIV non-disclosure and use motivational interviewing (MI) to support participants in setting and achieving personal goals. In this randomized control trial phase of the research, the investigators are assessing the efficacy of the group counseling intervention, GPS. Participants are randomized to receive GPS immediately or to a wait list/standard of care condition. Participants are followed for a 6 month period and are asked to complete baseline quantitative assessments, as well as two qualitative interviews.
Chronic hepatitis C virus (HCV) is a major cause of morbidity and mortality worldwide with an estimated number of 180 million infected patients. Until 2012 the current standard of care (SOC) treatment of patients with chronic hepatitis C was a 24 to 72 weeks therapy with pegylated interferon- and ribavirin (PR). In 2012, the protease-inhibitors (PI's) telaprevir and boceprevir as first directly acting HCV drugs have been approved by the local Swiss authority for hepatitis C mono-infected and HCV-HIV-co-infected individuals. However, therapy success is strongly limited in null-responders (NR) to previous PR. Treatment of HCV-HIV co-infected individuals with the new PI's is accompanied by additional challenges (e.g. drug-drug interactions, toxicity, high pill burden). Patients with advanced fibrosis are at highest risk for decompensated liver disease and hepatocellular carcinoma (HCC) and prompt initiation of treatment is strongly recommended. Recently, data in mono-infected patients showed, that in prior non responders a 12 week course of a triple therapy (TT) with telaprevir and PR followed by another 24 weeks of PR resulted in an sustained virologic response (SVR) of only 29%. In HCV-HIV co-infected non-responders with unfavourable preconditions (e.g. HCV-genotype 1, interleukin 28 B non-CC genotype, advanced liver fibrosis, high baseline HCV viral load) SVR after TT is even expected to be lower. These patients urgently need additional therapeutic options with the goal to eradicate HCV in order to prevent further fibrosis progression and to reduce morbidity and mortality. A promising substance in the field of drugs targeting the HCV replication is silibinin. Silibinin is the main component of silymarin, an extract of the milk thistle Silybum marianum. Intravenous silibinin (iSIL) targets multiple steps in the virus life cycle and exhibits anti-oxidant, anti-inflammatory, anti-viral and immunomodulatory properties. iSIL inhibits the HCV NS5B polymerase activity directly or by interfering with the binding of RNA to this enzyme. In addition, iSIL appears to block virus entry, virus transmission and virus secretion.In 2008 Ferenci et al. for the first time reported the substantial clinical antiviral-effect of intravenous silibinin (iSIL) against HCV in PR non-responders. The administration of 20mg/kg iSIL in 20 patients led to a highly significant decrease in viral load. We intend to investigate the effect and tolerability of iSIL in HIV-HCV co-infected individuals with advanced liver fibrosis and previous non- or partial response to SOC. All included study-subjects will receive a lead-in therapy with iSIL in a dosage of 20mg/kg/day (expressed as silibinin concentration) once a day for 14 days. At the end of the THISTLE study, i.e. after the day of completion of the 14-day iSIL administration (day 15), the patients will be considered for eligibility to receive standard of care. We assume that the decline in HCV viral load would substantially improve the chances of SVR as the reduction of viral load should both increase the efficacy of PR and reduce the odds of drug resistance to HCV-specific protease inhibitor. - Trial with medicinal product
The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.
This study will recruit men and transgender women with acute or recent HIV infection. It wil look at how HIV medicines (ART) when given very early after HIV infection affect the amount of HIV in the blood, semen and rectal secretions. In addition, Investigators will be using modeling studies to look at whether or not this kind of HIV treatment can decrease the risk that a man will infect a person he has sex with and to find out how failure to take medications will impact spreading the virus to other people. In this study, one group will be randomized (like a coin toss) to start ART immediately (just at the time of the enrollment visit) and the other group will wait until week 24 of the study to start ART. Both groups will be followed for a total of 48 weeks and will continue to receive ART from local sources after the study is over.