Active clinical trials for "Acquired Immunodeficiency Syndrome"

The primary objective of this study is to assess the safety of probiotics in cART-treated immunologic non-responder (INR) patients with chronic HIV infection. The secondary objectives are to i) explore the biological effects of probiotics in combined antiretroviral therapy(cART)-treated INR patient with chronic HIV infection, and ii) investigate differences between cART-treated HIV-infected INR and non-INR patients with regards to gut microbial composition and mucosal barrier function.

This study will evaluate how safe Budigalimab is and how it moves within the body in adult participants with HIV-1 infection. Budigalimab is an investigational drug being evaluated for the treatment of Human Immunodeficiency Virus. Study participants will be assigned to one of the 4 treatment groups and will receive a single dose of Budigalimab or placebo subcutaneous (SC) and intravenous (IV). Around 32 participants 18-65 years of age living with Human Immunodeficiency Virus will be enrolled in the study in approximately 9 sites worldwide. Each participant will receive single dose of SC and IV Budigalimab and/or Placebo on day 1 and will be followed for 24 weeks. Participants will attend weekly to every two and every four weeks visits during the study at a hospital. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects. There may be higher treatment burden for participants in this trial.

The study seeks to reduce HIV/AIDS-associated stigma and its negative impact on adolescent health and psychosocial well-being. This study will examine two evidence-informed interventions: 1) group cognitive behavior therapy (G-CBT) that aims at cognitive restructuring and strengthening coping skills at the individual level, and 2) multiple family group (MFG) that strengthens family relationships intended to address HIV/AIDS-associated stigma at the individual level and within families. Adolescents between 10-14 years, will be randomly assigned -at the clinic level, to one of three study arms: 1) Usual care to receive the currently implemented usual care addressing HIV/AIDS-associated stigma (educational materials from the Ugandan Ministry of Health); 2) G-CBT intervention + Usual care; and 3) MFG intervention + Usual care. The interventions will be delivered over a 3-month period. Assessments will be collected at baseline, 3 months and 6 months post intervention initiation. The study will also explore participants, caregivers and facilitators' intervention experiences, as well as multi-level facilitators and barriers to intervention implementation and participation.

The proposed study is a phase 1, open label, single arm study to evaluate the safety, pharmacokinetics and antiviral activity of single intravenous infusions of 3BNC117-LS and 10-1074-LS, each monoclonal antibody (mAb) dosed at 30 mg/kg in viremic human immunodeficiency virus (HIV)-infected individuals.

The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of HIV and pulmonary tuberculosis and to determine the rational of its use.

Background Active Hexose Correlated Compound is assumed to have a positive effect on immunity, including induce a phagocytic response, reduce tumor resistance, and cytokine response including interferon-gamma and interleukins. Tuberculosis patients with concurrent Human immunodeficiency Virus (HIV) might have benefit when receiving active hexose compound during tuberculosis treatment Purposes To assess the clinical changes of patients who receive active hexose compound as an adjuvant to tuberculosis therapy in patients with HIV To assess the difference of pro-inflammatory cytokines between standard therapy and active hexose compound adjuvant Methods A clinical trial involving patients with Tuberculosis-HIV infection Hypothesis Clinical improvement is significantly different where the group who receive active compound will have the better clinical outcome Lower proinflammatory cytokines are observed in people who receive active compound

The study aims to evaluate the safety and efficacy of a 2 drugs ART regimen (lamivudine plus dolutegravir) for prevention of mother to child transmission in pregnant women with HIV. 20 pregnant women will be enrolled in this proof of concept protocol. They will be prescribed DTG-3TC (fixed-dose combination), and will be followed up to the end of gestation. Initially, a total of 10 pregnant women will be recruited for the first phase of the study. Once the first phase is successfully completed, 10 additional participants will be included in a second step.

The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.

With the increasing age of people living with HIV/AIDS, age-induced osteoporosis is likely to be compounded by HIV/AIDS and HAART-associated bone loss. Mechanistically, osteoclasts the cells responsible for bone resorption form under the influence of the key osteoclastogenic cytokine receptor activator of nuclear factor kappa-Β ligand (RANKL). The osteoclastogenic and proresorptive activities of RANKL are moderated by its physiological decoy receptor osteoprotegerin (OPG). Imbalance in the ratio of RANKL to OPG alters osteoclastic bone resorption and lead to osteoporosis. Activated T- and B-cells are a major source of RANKL, while normal physiological B-cells are a major source of OPG. T-cells regulate the production of OPG by B-cells. Thus changes in the immune system induced by HIV/AIDS and/or by HAART could affect B-cell and T-cells RANKL and OPG production. Indeed, data from our group shows that in an animal model of HIV/AIDS, the HIV-1 Transgenic rat, the development of osteoporosis is recapitulated as observed in HIV-infected patients, and B-cell OPG and RANKL production are concurrently down regulated and upregulated respectively. Furthermore, preliminary data in HIV-infected subjects suggests dramatic acute upswing in bone resorption following HAART initiation that peaks at 12 weeks and then declines. Based on these findings, the investigators hypothesize HAART associated bone loss is driven by immune reconstitution. Because this effect of HAART is dramatic in magnitude but short in duration, the investigators propose to apply antiresorptive agent (zoledronic acid, reclast®) to specifically spare patients from this dramatic but acute bone damage.

This study is a Phase II single arm, open-label, multicenter, study of 50 human immunodeficiency virus-1 (HIV) infected adult patients, all of whom will receive etravirine (ETR) 400mg and DRV/r 800/100mg each given orally once daily. This trial is designed to evaluate the efficacy of the aforementioned ARV regimen, as measured by the percentage of patients with HIV RNA <50 copies/mL at 48 weeks, in early treatment-experienced HIV-infected patients. In addition to general safety parameter measurements, this trial will also assess changes in metabolic, inflammatory, immune restoration, and bone markers. Screening will occur over a 6-week period. The primary endpoint will be assessed at Week 48, and the treatment period is 48 weeks. The end of study endpoint will be met by either completing the Week 48 visit, or by early termination from the study for any reason.