View clinical trials related to HIV Infections.
Filter by:Cardiovascular disease (CVD) has been associated with HIV infection. However, it is uncertain whether increased CVD rates are associated with HIV-related factors (e.g., HIV-infection or highly active antiretroviral therapy (HAART) may worsen dyslipidemia) or reflect differences in the prevalence of underlying risk factors for CVD. Furthermore, the association between initiation and duration of HAART exposure and CVD risk, including which specific drugs within the HAART classes may contribute to the increased risk, is unknown. The primary objectives of the study are therefore: 1. To estimate the absolute and relative incidence rate (IR) of CVD claims-based diagnoses among a cohort of adult patients from a large managed care population with a claims diagnosis of HIV, AIDS, or AIDS-related complex (ARC) during periods of exposure to: - Any HAART compared to no HAART exposure - HAART class [i.e., NRTIs, NNRTIs, PIs, and Other (i.e., fusion inhibitors)] compared to no HAART class exposure - Specific NRTI medications compared to no specific NRTI exposure
APV10017 was a pharmacokinetic study that evaluated the pharmacokinetics, safety and tolerability of fosamprenavir/ritonavir (FPV/RTV) at reduced doses over 14 days in HIV-infected subjects with mild to moderate hepatic impairment (HI). Based on these data, two new regimens have recently been approved by the EMEA and FDA in these patient groups; FPV 700mg BID/RTV 100mg QD for those with mild HI (Child-Pugh score 4-6) and FPV 450mg BID/RTV 100mg QD for those with moderate HI (Child Pugh score 7-9). The Committee for Medicinal Products for Human Use (CHMP) has requested longer-term safety data among this hepatically impaired HIV-infected population who have received the recently updated FPV/RTV dosing regimens. An observational cohort study will be conducted using routinely collected data in three European HIV patient cohorts with a high proportion of hepatitis co-infected individuals. Patients who received FPV/RTV will be followed to address the following objectives. Primary: To assess the safety and tolerability of FPV/RTV-based ART in subjects with mild to moderate hepatic impairment. Secondary: A). To compare the safety and tolerability of FPV/RTV-based ART in subjects with mild to moderate hepatic impairment when compared to FPV/RTV-based ART in hepatitis B (HBV) or hepatitis C (HCV) co-infected subjects with normal hepatic function. B). To compare the safety and tolerability of FPV/RTV-based ART to lopinavir/ritonavir LPV/RTV-based ART in subjects with mild to moderate hepatic impairment.
This research is being done to learn how seminal fluid affects the lining of the colon, and whether this might make it easier for HIV to get into the body and cause infection.
The Principle objective of this study is To evaluate the performance of NRA, NRA-p and REMA-p for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using LJ and MGIT culture as gold standard. The Secondary objectives are: - To measure the performance of each assay (NRA, NRA-p, REMA-p) in sputum smear-negative patients - To describe the results of the colorimetric methods in HIV-positive and HIV-negative patients - To assess the time to detection of both NRA/NRA-p, REMA-p methods. - To evaluate the feasibility of the NRA, NRA-p, REMA-p methods. - To determine the rate of contamination of the NRA, NRA-p and REMA-p assays. - To evaluate the proportion and the clinical relevance of NTM among TB suspects in a high TB and HIV prevalence setting. - To provide capacity building for TB diagnosis in Mbarara.
Malaria is a major contributor of disease burden in Sub-Saharan Africa: 90% of global cases occur there, and pregnant women and children under 5 years are the most vulnerable. Malaria in pregnancy increases risks of abortion, stillbirth, prematurity, intrauterine growth retardation and maternal anemia, and is associated with higher risk of low birth weight and perinatal, neonatal and infant mortality. For prevention and control of malaria in pregnancy, the WHO recommends Intermittent Preventive Treatment (IPT) with antimalarial drugs, insecticide treated nets (ITNs) and effective treatment of malaria and anemia. HIV in pregnancy increases the risks of malaria, and it seems that the efficacy of IPT with the drug sulphadoxine-pyrimethamine (SP) is decreased in HIV+ pregnant women. Malaria prevention in pregnancy in Zambia relies on ITNs and IPT with SP. Daily prophylaxis with cotrimoxazole (CTX) effectively reduces mortality and morbidity in HIV+ individuals, and antibiotic therapy during pregnancy might help to decrease adverse pregnancy outcomes. CTX prophylaxis improves birth outcomes in HIV+ women with CD4<200/µl: a study concluded that antenatal provision of CTX was beneficial for HIV+ pregnant women with low CD4 but not in women with ≥200/µl (however, this study was carried out in an area with very low risk of malaria , and CTX may have a different effect depending on endemic conditions). The WHO recommends daily CTX in addition to ARVs, to prevent opportunistic infections in all HIV+ patients. Concurrent administration of SP and CTX may increase the incidence of severe adverse reactions in HIV+ patients, so WHO has promoted CTX prophylaxis as an alternative to SP for the IPT in immuno-compromised pregnant women. Unfortunately, there is insufficient information on the effectiveness of daily CTX for preventing malaria infection in pregnancy: so, SP is still the only antimalarial recommended by WHO for this purpose. With the increase in SP resistance and with the newer antimalarials still being studied for safety and efficacy in pregnancy, CTX could be an alternative for SP in reducing malaria and malaria-related morbidity and mortality in pregnancy. This study will try to to see if in HIV- and HIV+ pregnant women, CTX is not inferior to SP in reducing placental parasitaemia. Such information is needed to issue updated, effective guidelines on malaria prevention in pregnancy
The purpose of this study is to compare the drug levels of darunavir obtained after administration of a single administration of the 800 mg tablet (new formulation) to that following administration of two 400 mg commercial tablets formulation when administered under fed and fasted conditions to those also taking low-dose ritonavir. Darunavir is marketed for the treatment of HIV. The short-term safety and tolerability of darunavir following administration of a single 800 mg dose of darunavir given to healthy volunteers taking taking low-dose ritonavir will also be assessed.
Each year around 200 blood donors in the UK are found to be infected with blood-borne diseases (HIV, hepatitis B, hepatitis C, and HTLV), while several others have been identified as having an increased risk of variant Creutzfeldt-Jakob Disease (vCJD). Although the notification procedures for these infections vary, their effectiveness and appropriateness have never been evaluated in a systematic study. The proposed research has been designed to assess the responses of blood donors to notification and their satisfaction with how they were informed about the infection. The study will be implemented using standard questionnaire-based measures (French et al, 2004; Marteau & Bekker, 1992). The study will involve approximately 600 blood donors who were informed of an infection or possible infection with blood-borne diseases in 2008 and 2009, and approximately 100 donors notified of possible risk of vCJD infection in 2005. A comparable group of 2005 donors will be included to control for the effects of time. As the majority of donors testing positive donated to NHS Blood and Transplant (NHSBT), the participants will be identified from the NHSBT database only, and their availability confirmed through their GP or specialist clinician. A standardized questionnaire will be then sent to all those identified as eligible. The study will last 12 months, but direct participant involvement will be limited to the time required to complete the questionnaire, which should take under one hour. To safeguard confidentiality, no identifiable personal data will be used in the analysis. Where demographic or medical information already held by NHSBT is retrieved to minimise response burden, this will be pseudonymised before use. The study is sponsored by the blood services for England, Wales, Scotland and Northern Ireland. The results will be used to inform notification procedures in the future.
The specific aim of this proposed pilot study is to compare two standardized processes (paper and electronic) to deliver a customized MedlinePlus health information prescription.
This is a two-phase study that is designed to test a novel behavioral intervention to treat depression in Human Immunodeficiency Virus (HIV) adolescents and young adults. Four Adolescent Trials Network (ATN) sites will be assigned to either the Combination Cognitive Behavioral Therapy and Medication Management (COMB) treatment group or the Treatment as Usual (TAU) group. Phase I involves pilot testing of a 24-week intervention consisting of Cognitive Behavioral Therapy (CBT) and Medication Management (MM) manuals at sites assigned to the COMB treatment group. Participants enrolled at TAU sites will receive treatment for depression that is typical at that site, which may include medication management, psychosocial therapy, or a combination of the two. Psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Study coordinators and site clinicians, regardless of group assignment, will document depression symptoms and treatment regimens for all participants for 24 weeks. In addition, site staff and participants at COMB sites will participate in an exit interview. The findings from these interviews will be used to revise both CBT and MM intervention manuals at the end of Phase I. Phase II is a feasibility study of the revised CBT and MM manuals. Phase II involves similar procedures as Phase I; sites assigned to COMB will implement the revised CBT and MM manuals. Participants at TAU sites will receive treatment for depression that is typical at that site. As in Phase I, psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Depression symptoms and treatment regimens for all participants will be documented for 24 weeks. Additionally, all Phase II participants will have 2 follow-up visits at weeks 36 and 48. Again, site staff and participants at COMB sites will participate in an exit interview. The findings from these interviews will be used to revise both CBT and MM manuals at the end of Phase II.
This study will use a longitudinal, experimental design. Participants will be randomized to either the intervention or the control group. The intervention will involve cell phone support, including reminders, assessment of barriers to adherence, problem solving and referrals conducted by an Adherence Facilitator. Control group participants will participate in all on-study evaluations, except the intervention exit interviews.