Active clinical trials for "HIV Infections"

Two previous studies of an HIV preventive vaccine, the STEP study and the Phambili study, were halted because people who received the vaccine were more likely to become infected with HIV. Why this vaccine failed is still being researched, but one reason may be related to the recombinant Adenovirus type 5 (rAd5) virus vector used in the vaccine. Two trials of another HIV preventive vaccine that used a rAd5 virus vector were conducted in Uganda. This study will obtain follow-up safety information on participants in those trials.

Current measures of adherence detect problems weeks to months after they occur. Because the HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral therapy, treatment failure may develop before an intervention can be deployed. Real-time objective adherence monitoring could redirect efforts from a reactive response to the proactive prevention of treatment failure. Because adherence is so closely associated with viral suppression, accurate adherence monitoring could also strategically limit viral monitoring only to those patients at a defined risk for viral rebound. This observational study is assessing a wireless adherence monitoring device and mobile phone-based adherence data collection among caregivers of children under the age of ten years in Mbarara, Uganda. It involves both quantitative and qualitative measures of the feasibility and acceptability of these measures, as well as circumstances of adherence lapses and other individual and cultural factors affecting adherence. The qualitative data will be used to explore models of adherence behavior, which will likely include the child-caregiver dynamic, the child's mental and physical health, and social support mechanism.

The World Health Organization has estimated that as many as 10% of the population worldwide may at some point experience at least one seizure. The percentage with active epilepsy is from 0.4% to 1%. From 40% to 65% of patients with HIV infection have been estimated to have some neurological involvement; the percentage reaches as high as 70% to 80% when post-mortem assessments are included. Estimates of the percentage of HIV-infected patients with seizure occurrence have varied widely, with one review finding a range from 2% to 20%. The highest percentage in this range was reported at a center that exclusively treated patients with neurological involvement, in India where HIV clade C subtype is predominant. Query of another neurology department's database determined that of the HIV-infected patients treated at the center, all of whom were referred for neurological symptoms, 6.1% experienced seizures. Underlying neurologic diseases in these patients included HIV-associated encephalopathy, progressive multifocal leukoencephalopathy, and toxoplasmosis. In a Spanish population, 3% of HIV-infected patients over a one-year study period were found to have new-onset seizures, which were attributed to drug toxicity in 47%, intracranial lesions in 35%, and metabolic derangements in 12%. Drug-discontinuation studies, magnetic resonance imaging studies, and animal studies have produced recent evidence that some antiretroviral therapies may have neurotoxic effects, warranting further research. Individuals who are treated with highly active antiretroviral therapy are at risk for immune reconstitution inflammatory syndrome (IRIS), in which immune recovery triggers clinical deterioration as the newly invigorated immune system reacts to pathogens that either represent ongoing opportunistic infection or were previously successfully controlled. In a population initiating combination antiretroviral therapy between 1999 and 2007, 0.9% developed neurological manifestations of IRIS. Seizures may occur as part of a neurological IRIS syndrome, such as encephalitis and toxoplasmosis. Two randomized, Phase 2b dose-finding studies were conducted in HIV-1 infected adults to compare GSK2248761 100 mg and 200 mg given once daily as part of an antiretroviral treatment regimen. One of the studies (SGN113399) was in subjects with prior exposure to antiretroviral therapy where GSK2248761 100 mg and 200 mg once daily were compared to determine the best dose in this population. A contemporary control arm receiving etravirine 200 mg twice daily was also included, and all arms included a twice-daily background therapy consisting of darunavir/ritonavir 600 mg/100 mg plus raltegravir 400 mg. The other study (SGN113404) was in treatment-naïve subjects, comparing GSK2248761 100 mg and 200 mg once daily to determine the best dose in this population. A contemporary control arm receiving efavirenz 600 mg once daily was also included, and all arms were given background therapy selected by investigators from either once-daily abacavir/lamivudine 600 mg/300 mg or tenofovir/emtricitabine 300 mg/200 mg. Of a planned total population in both studies of 300 subjects, 35 were enrolled before the studies were terminated because of the occurrence of seizures in five subjects. All of the subjects who experienced seizures were enrolled into SGN113399, four randomized to receive 200 mg GSK2248761 and one randomized to receive 100 mg GSK2248761. There were no seizures in the subjects receiving GSK2248761 in study SGN113404. At the time of study termination, subjects had been enrolled and received GSK2248761 at 19 sites in four countries: France, Romania, United States, and Germany. Although potential contributory conditions have been identified in some cases, definitive causative factors for the seizure occurrence have not been established. The purpose of this study is to follow subjects who previously received GSK2248761 while enrolled in the Phase 2b studies, which were halted due to unexpected seizures. The study will collect data on all subjects and will be used to monitor for additional seizures as well as collect additional clinical data on all subjects.

This study is to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.

The investigators propose a prospective single arm pilot cohort study of 100 youth (ages 15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be enrolled on a voluntary basis from those who come to the day care center located in Nyanza, a district of the Southern province, in Rwanda.

The main objective of this one year multidisciplinary research is to estimate the frequency of seropositive men having sex with men (MSM) under antiretroviral therapy (ART) having an undetectable blood viral load (VL) and a detectable VL in semen. Design: Participants'inclusion (n=150) will be done in 6 HIV hospital departments participating to the research project. To warrant feasibility and diversity of participants needed, the centers will be located in Paris and nearby suburbs. The study design is based on one blood and semen sample taken at day 0 and at day 30. Blood and semen samples will be taken in the enrolment centers. Biological and virological analyses will be performed by the laboratory of microbiology at Necker hospital, on blood and semen samples. Pharmacological analyses are planned in a subsequent study. Socio-behavioral data will be collected through a self-administered questionnaire at day 0 and day 30. Schedule: Patients' enrolment, collection of biological samples and questionnaires will last 10 months (end of first quarter 2012). Biological and virological analyses will be performed until the end of the first semester 2012. Quantitative and socio-behavioral data will be analyzed during the third quarter 2012. Results will be released at the beginning of year 2013.

The purpose of this study is to determine whether the current dose of nevirapine recommended in the Ontario Ministry of Health vertical transmission prevention protocol achieves therapeutic drug levels in newborn infants at high risk of HIV infection.

The purpose of this study is to understand how best to provide care and treatment services to human immunodeficiency virus (HIV) positive pregnant women and their babies in Swaziland. The study is designed to evaluate a new approach for Preventing Mother-to-Child Transmission (PMTCT)where all HIV positive pregnant women initiate lifelong triple antiretroviral (ARV) therapy regardless of their disease stage. The goal is to prevent delays in women accessing treatment for their own health and ensure that women and their children remain in care. This study will compare this new approach to PMTCT, known as Option B+, to Option A, which is the current standard of care for PMTCT in Swaziland. The study will be conducted at 10 health facilities in the Manzini and Lubombo regions in Swaziland. The study has three components: the main component is a PMTCT Options Evaluation where data from medical records will be abstracted on all HIV positive pregnant women attending antenatal services at the 10 selected study facilities; data will be abstracted on their HIV exposed infants as well. Other components of the study include a PMTCT Options Acceptability Evaluation using semi-structured questionnaires with PMTCT clients and health care workers (HCWs) as well as a cost effectiveness evaluation comparing costs under conditions of Option A and Option B+.

Background: Cervical cancer is a major cause of cancer deaths among women. Most cases of cervical cancer are caused by the human papillomavirus (HPV). HPV is more common in women who have the human immunodeficiency virus (HIV). India has one of the highest rates of women who have both cervical cancer and HIV infection. Cervical cancer can be discovered in early stages by screening for HPV infection. Researchers want to compare new cervical cancer screening tests for HIV-infected women. They also want to know more about how HPV can lead to cervical cancer in HIV-infected women. To do so, they will hold a study to screen HIV-infected women in India. Objectives: - To improve cervical cancer screening methods in HIV-infected women in India. Eligibility: Women at least 18 years of age who have HIV infection. Participants will be recruited from HIV-focused health care clinics in Pune and Chennai, India. Design: Participants will have a physical exam and medical history. They will provide a urine sample and proof of HIV infection. Participants will have a gynecological exam. This will involve a pelvic exam and Pap smear to collect cells for study. It will also involve a cervical exam to look for precancerous cells. Cervical tissue may be collected. Participants will also provide a blood sample for testing. Participants will return in 2 weeks for the test results. If there are signs of precancerous or cancer cells, participants will be referred to a doctor for treatment.

To conduct a multicenter epidemiologic study of the human retroviruses HIV-1, HIV-2, HTLV-I, and HTLV-II in volunteer blood donors from areas of the United States that were reportedly at high and medium or low risk for HIV. Also, to determine the prevalence of retrovirus seropositivity in first time blood donors; and the rate of retrovirus seroconversion in repeat blood donors as a measure of incidence of infection; to ascertain risk factors for antibody-positive donors; to characterize the blood donor population by geographic location, age, sex, race/ethnicity, and donation history to permit analysis on prevalence, incidence, and risk factors; to identify recipients of retrovirus-positive blood units and conduct clinical and laboratory follow-up of these recipients; and to establish a blood specimen repository for long-term storage of specimens from study donors and recipients for future testing.