View clinical trials related to AIDS.
Filter by:Background: The incidence of lung cancer is quite high among people with the human immunodeficiency (HIV) virus. Frequent smoking may explain that cancer increase, given that 50% to 70% of HIV-infected people are current smokers. Recent research suggests that other factors may be involved as well. Smoking habits, such as smoking earlier in life or smoking more cigarettes a day than others do, may have a role. Also, HIV-infected smokers seem to have a greater risk of chronic obstructive pulmonary disease (COPD). The association of HIV and COPD is important, because COPD itself is linked to an increased risk of lung cancer. About 1,600 subjects from the study known as ALIVE (AIDS Linked to the Intra-Venous Experience), which began in 1988 in Baltimore, Maryland, will be given a detailed questionnaire on smoking behaviors and lung cancer risk factors. They will also have spirometry testing, to evaluate lung function. Objectives: To better characterize smoking habits and compare tobacco use among HIV-infected and uninfected drug users. To compare serum cotinine levels and spirometry results, as a marker of tobacco use and a marker of damage to lung function, respectively. Eligibility: Patients 18 years of age and older who are in the ALIVE cohort. Design: Patients undergo the following procedures: - Completing a questionnaire on smoking history. Questions include age when smoking began, periods of quitting smoking, average number of cigarettes per day for specific periods, amount of each cigarette smoked, depth of inhalation, type of cigarette, nicotine dependence, use of other smoked [Note: I would not mention that these drugs are illegal] drugs, exposure to environmental tobacco smoke, past medical history, and recent respiratory symptoms. - Spirometry testing. Patients are asked to breathe as deeply as possible and then rapidly exhale into a tube. The forced expiration volume in 1 second reflects the average flow rate during the first second, and it can be used to determine the degree of pulmonary obstruction. - Blood samples. Tests measure levels of cotinine, a chemical made by the body from nicotine. African American males, who constitute the majority of the ALIVE cohort, participate in this test. Results would show how much tobacco smoke has recently entered the body. For this test, researchers plan to evaluate 240 current tobacco smokers and 100 participants who report no recent cigarette use.
The exposure of human beings to markedly altered environments (ambient pressure and inhaled gas mixtures) has profound effects on their innate immune capacity to effectively combat viral illnesses. This Phase IIA clinical trial examines the effects of an exposure to a 4 atmospheric environment has on HIV-infected humans whose clinical condition has progressed to formal AIDS status.
GSK has constructed a new HIV immunogen comprised of conserved parts of the HIV virus (gag, pol and nef). The principal objectives of this study are to evaluate the reactogenicity and safety of this candidate vaccine with or without a GSK proprietary adjuvant system at three different doses and to evaluate the CD4+ T-cell response in terms of proportion of responders to the antigens two weeks after the second vaccination.
LOTTI study Centers This a multicenter, multinational study. Clinical phase: III Objectives The primary objective is to compare efficacy and safety of continuing a conventional HAART in chronically infected HIV patients with a therapeutic strategy based on long term, immunologically driven treatment interruptions. Secondary objectives are: - To verify the risk of developing viral resistance - To verify the effect of the two strategies on metabolic parameters - To verify the possibility to steadily discontinue antiretroviral therapy in patients who started it with baseline immunological values higher than those currently recommended by international guidelines for HIV treatment - To identify predictive variables of the possibility to safely discontinue antiretroviral therapy - To verify the dynamic of CD4+ cell loss and HIV replication after treatment interruption Number of Patients: A total of 320 patients. Study design: Controlled, Randomized, Open study The study will last 5 years Treatment arms: Patients will be randomized in a ratio 1:1 to one of the two treatment arms Control group continuing the ongoing therapy STI group performing long term CD4 guided structured treatment interruptions In the STI arm patients will stay off therapy until their CD4 count will drop < 350 cells/mcL (one measurement will be considered sufficient). At that time point patients will resume the HAART regimen they were assuming before STI and will continue HAART until they CD4 count will raise > 600 cells/mcL (at least 2 consecutive measurements 2 months apart) and their HIV-RNA will drop below the detection limit of 50 copies/ml (one measurement will be considered sufficient). When both the CD4 count and the viral load will be within these pre-set values they will stop therapy again. There is no limit to the number of interruptions and re-start cycles during the study period End points: The primary end-point for the evaluation of the main objective of the study will be clinical. The primary outcome measure will be based on the occurrence of a clinical end-point defined as: disease progression (occurrence of any AIDS defining event), death for any cause or the occurrence of clinical events requiring hospital admission The secondary objectives of the study will be evaluated on the basis of: - Mean variation of blood cholesterol and triglycerides from baseline values. - Development of lipodystrophy or modification of a pre-existing lipodystrophy - Time off therapy. - Variation of CD4 counts and HIV-RNA levels - Genotypic tests to be performed in the case of HIV-RNA > 1000 copies/ml while on therapy for at least 4 months or one month after each treatment interruption. Statistics: The study is powered to evaluate equivalence between the two strategies under the assumption that, in the control arm, the primary end-point would be observed in a proportion of subjects < 7% and that the same proportion in the STI arm would not exceed 10% with a maximum allowed 95%CI of 12%. 320 patients will be needed for alfa = 5% and 1-beta = 80%. The primary analysis will be made according to the intention-to-treat approach and therefore no correction for eventual drop outs is needed. In addition, a secondary per-protocol analysis will be performed.
Kaposi's sarcoma (KS)is the commonest malignancy associated with HIV/AIDS. Therapy for this cancer, which causes substantial morbidity, is suboptimal in resource poor settings. The reasons for this are: advanced state of immunosuppression when patients present for clinical care, concomitant opportunistic infections, non- availability of antiretroviral therapy (ART), non-availability and toxicity of chemotherapy (CXT), when available, in patients with full blown AIDS, prohibitive costs of bone marrow support and fiscal constraints in resource poor settings. A recent Cochrane Review assessed the effectiveness of current therapeutic regimens for HIV KS, with a focus on options available in resource poor settings. The major selection criteria for this review were randomized controlled trials for HIV KS in adults. The main conclusions were that data from randomized controlled trials on effective treatments for HIV KS are sparse, particularly among people who are also taking highly active antiretroviral therapy (HAART). Alitretinoin gel is effective for therapy of cutaneous lesions, pegylated liposomal doxorubicin is effective for advanced KS and radiotherapy is effective for treating cutaneous lesions. Apart from the randomized trial of radiotherapy, no trials applicable to developing settings were identified. Therapy of HIV KS in developing countries thus remains unanswered. The authors concluded that therapies discussed in the review are unlikely to be available or affordable in developing countries where the bulk of HIV infection and KS occur, apart from radiotherapy at a few tertiary centers. However, recent changes in pricing due to the global alliance and access initiatives mean that HAART is likely to be more available and accessible to developing countries in the near future. South Africa now has committed to this at cabinet level and had a task force to address this issue. HAART has been proposed as therapy for HIV KS on the basis of restoring immune competence and minimizing the HIV tat drive to KS formation. It also improves immunologic control of HHV 8 possibly through interrupting the HIV-1- HHV-8 interaction. There has been only one randomised trial conducted in Spain which compared HAART to the combination of HAART and CXT. There is to date no prospective, randomised controlled trial which compares the efficacy of HAART to the standard of care in HIV KS in Africa.
After Initiation of HAART in peoples who living with HIV/AIDS in Thailand by the year 2000, rapidly expanded HAART access of national project has been promoted in 2004. Free ARVs (For CD4<200cell/cu.mm. or in symptomatic HIV with CD4<250 cell/cu.mm. )and CD4 monitoring has been available. The first-line regimen is d4T+3TC+NVP in mainly the first time (Naive) patients. CD4 response ), rate of opportunistic infection, and neurological outcomes were measured. Rate of ARV change, adverse events,treatment failure, TB co-infection rate, percent changing to EFV-based regimen or PI-based regimen were recorded. Any Adverse Events including, Sever rash, Severe Hepatitis, Lipid abnormalities, Severe Anemia and Other, common AEs will be analysed.
Neurological manifestations of Cerebral toxoplasmosis or Toxoplasmic encephalitis (TE) in most advance stage HIV infected patients composed of fever, headache, alteration of consciousness with focal neurological signs/symptoms such as include hemiparesis, cranial nerve palsies, and ataxia. Generalised convulsions, in ¾ of patients. Moreover meningeal irritation sign or herniation sign may be presented as life threatening condition
The objective of this proposal is based on the assumption that the HIV infected Ethiopian population responded in a different way in comparison to the Caucasian subjects to Lopinavir therapy. Our preliminary data demonstrated that Ethiopian's have different Lopinavir serum concentration in comparison to non-Ethiopian's. For these reasons the plan of this study is to investigate the pharmacokinetic/pharmacodynamic (PK/PD) profile in both populations. The results will allow to establish a better personalised medicine for HIV infected individuals.
The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in HIV-infected patients with hypertriglyceridemia. In addition, we, the researchers, will evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and inflammation.
Study Hypothesis Evaluation of the durability of the combination Tenofovir and Hydroxyurea to maintain viral suppression below 50 copies/ml in volunteers who have achieved viral suppression on a standard HAART regimen.