View clinical trials related to HIV Infections.
Filter by:This study will compare the benefit for patients switching from Kaletra® to Invirase® tablets over remaining on Kaletra® (based on randomization), to elicit the lipid benefits inferred in previous studies
The introduction of highly active antiretroviral therapy (HAART) has dramatically changed the consequences of an HIV infection, which is now viewed as a chronic disease. As in other chronic diseases, emotional distress and depressive symptoms are highly prevalent in HIV-infected patients. Psychological factors such as these have been associated with lower quality of life, lower adherence to therapy and also with a higher risk for mortality and disease progression. Psychosocial interventions, such as group-based cognitive behavioral stress management (CBSM) training, have been shown to reduce distress and psychological symptoms in HIV-infected patients. These psychosocial effects are paralleled by changes in physiological parameters, such as cortisol, DHEA-S, testosterones, catecholamines, and naìˆve T-cell counts. While these results are congruent with recent evidence of the interaction between psychological, neuroendocrine and immunological parameters in HIV-infected patients, it needs to be shown whether the reported effects hold true in the HAART era. Most importantly, it also needs to be ascertained whether these interventions have an impact on immunological and virological HIV parameters as well as on mortality and morbidity in HIV patients. We propose a randomized controlled one-year prospective evaluation of a group-based CBSM training in 80 HIV-infected patients. Participating patients will be recruited at cooperating centers of the Swiss HIV Cohort Study and randomly assigned to CBSM training or waiting control group condition. At baseline, post-training and two follow-up (6 and 12 months) assessments, effects of the CBSM on psychological, physiological and clinical out-come variables in HIV-infected patients under HAART will be evaluated. Additionally, the effects of CBSM on the neuroendocrine and autonomic stress reactivity in HIV-infected patients will be assessed, thus evaluating a possible direct pathway between emotional distress and physiological HIV-relevant parameters. In conclusion, the planned research project evaluates the effectiveness of a standardized psychosocial intervention as a possible component of a comprehensive disease management in HIV-infected patients under HAART.
This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly with 2 to 3 active nucleoside reverse transcriptase inhibitors. The study will compare a group of HIV patients without known liver disease and a group with moderate liver disease. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
In this research project, we will study the genetic determinants that influence the pharmacokinetics of antiretroviral drugs used in the treatment of diseases caused by the HIV.
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.
This study will examine whether HIV-infected patients are more likely to develop resistance to antiretroviral therapy if their blood is not monitored for the number of viruses (viral load) in the body. A virus that changes (mutates) over time may become resistant to certain types of medicine. This resistance may affect future treatment options. This study will compare the amount of virus in the blood of HIV-infected patients who have been monitored for viral load with the amount of virus in the blood of patients who have not been monitored for viral load. For patients who have detectable virus, the type of resistance (mutations) of the virus will be determined by comparing the components of the virus with that of a virus that is known not to be resistant. HIV-infected patients 18 years of age or older who are being treated at the Infectious Diseases Institute at Mulago Hospital at Makerere University in Kampala, Uganda, may be eligible for this study. Participants are interviewed about the treatments they have received for HIV and how they usually take their anti-HIV drugs. They also have a blood sample drawn for research tests.
The purpose of this study is to observe the effects of certain anti-HIV medications on mitochondrial activity and fat cell death. This study will enroll participants from another study, ACTG A5202, who are on treatment regimens that do not include zidovudine, stavudine, or other thymidine-containing anti-HIV medications.
Women represent an increasing proportion of HIV cases globally and in Canada, yet are underrepresented in clinic trials. It is therefore critical to conduct this study on antiretroviral (ARV) pharmacokinetics (PK) in women to obtain additional information on ARV drug levels in women and their relation to adverse events (AEs). The hypothesis for this study is three-fold: 1. that the mean drug levels (Cmin and Cmax) of ARVs will be significantly higher in our female population as compared to the mean drug levels in the historical HIV population (which is primarily men) 2. that ARV drug levels, particularly Cmin, are associated with body weight in women 3. that higher ARV drug levels, particularly Cmax, are associated with higher frequency and severity of AEs. The objectives of this study are as follows: Primary objectives: 1. To demonstrate that levels of Protease Inhibitors (PIs) and Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) are significantly higher in our female population as compared to the mean drug levels in the historical general population (which is primarily men). 2. To determine the association between PI and NNRTI minimum concentration (Cmin) and body weight in our female population. Secondary objectives 1. To determine the association between maximum concentration (Cmax) and the frequency and severity of AEs as measured by the proportion of patients with grade 2 or higher laboratory or clinical AEs and the Symptom Index Score in women. 2. To determine the association between ARV drug levels and age, race, height, body mass index, adherence, hormonal levels and therapy, menstruation history, duration of HIV infection, duration on ARV therapy, baseline viral load, baseline CD4 count, present CD4 count, hepatitis B or C infection, class of ARVs, presence of ritonavir and other medications.
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.
Since 2004, the Thai Ministry of Public Health has massively scaled up antiretroviral treatment programs to provide therapy to more than 80,000 patients with partial support of the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM). As access to HIV care continues to expand under the universal health coverage system, it is important to document and analyze the efficacy, tolerance, toxicity and acceptability of antiretroviral therapy within pilot treatment programs, to provide evidence based feedback and recommendations to the national program and policy makers.