Active clinical trials for "HIV Infections"

The primary purpose of this study is to study the safety and tolerability of a HIV drug and to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected patients

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.

A randomised controlled trial to investigate three methods to reduce early mortality in adults, adolescents and children aged 5 years or older starting antiretroviral therapy (ART) with severe immuno-deficiency. The three methods are: (i) increasing the potency of ART with a 12 week induction period using 4 antiretroviral drugs from 3 classes (ii) augmented prophylaxis against opportunistic/bacterial infections and helminths for 12 weeks (iii) macronutrient intervention using ready-to-use supplementary food for 12 weeks.

In the proposed R34 grant, the investigators will develop and test a strategy of immediate fast-track care. The study population will include adult patients with early HIV infection. Participants will be randomized to immediate fast-track or standard (deferred fast-track) care. All participants will receive same-day HIV testing and ART initiation prior to study enrollment. The intervention group will receive immediate fast-track care, which is conditional upon timely visits, and after 24 weeks in care, an undetectable viral load (HIV-1 RNA <200 copies/ml). The standard group will be eligible to start fast-track care at 24 weeks, if they are on time for that visit and have an undetectable viral load. Participants in either group who are >3 days late for any fast-track visit will lose fast-track care for that visit; those in either group with detectable viremia on their 24-week viral load test will be evaluated by a physician, with follow-up visits every 4 weeks until they have an undetectable viral load. Participants will be followed for 48 weeks. With the proposed pilot study, the investigators aim to conduct the formative work that is necessary to successfully implement a future clinical trial with the same primary outcome. The investigators hypothesize that immediate fast-track care will result in higher retention with viral suppression.

The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and prevention of HIV infection. CAB possesses attributes that allow formulation and delivery as a LA parenteral product. CAB is being developed as both oral and long acting (LA) injectable formulations. This study is designed to evaluate the PK, safety, tolerability, and acceptability of CAB LA in adult HIV uninfected Chinese male subjects at low risk for HIV acquisition. Eligible subjects will receive oral CAB during oral phase of the study followed by CAB LA intramuscular (IM) injection during injection phase of the study. Approximately 60 subjects will be screened, of which, approximately 48 subjects will enter the oral phase and 40 subjects will enter the injection phase of the study. The maximum study duration will be approximately 89 weeks including oral phase, injection phase and follow-up phase.

Introduction Artemisia annua L is a medicinal plant traditionally used for treatment of malaria and other diseases in China. The extract of leaves of the plant has been demonstrated in-vitro to have potent anti HIV effects and in vivo to improve levels of lymphocytes in laboratory animals. Effect on lymphocyte stimulation has also been observed in non HIV persons taking the leaves of the plant as a tea for malaria prophylaxis in Uganda. Objective To determine the effect of A.annua L and Moringa oleifera leaf powder on CD4 cell count and other immunological indices in HAART HIV patients. Materials and Methods In this study Artemisia annua leaf powder and Moringa leaf powder will be investigated. The study will be a three arm randomized Phase II study involving adult patients with HIV-infection on HAART with CD4 below 350. The CD4 cell count, and other immunological indices in patients receiving HAART will be compared with those patients receiving additionally Artemisia annua powder with Moringa oleifera powder or Artemisia annua powder alone. The study will be conducted at the HIV clinic in Mbarara Regional Referral Hospital while laboratory tests will be done at Mbarara University of Science and Technology clinical and pharmaceutical sciences laboratories. Expected outcome The primary outcome will be change in mean (Median) CD 4 cell count. Secondary outcomes will be mean (or median) changes, viral load, complete blood count and other HIV associated immunological indices , Performance status and incidence of adverse effects like nausea, diarrhoea, weight gain and or loss. Expected benefits Adequate immunological recovery is one of the desired outcomes in HIV care. HAART combinations do not directly aid immunological recovery and some patients fail to have adequate immunological recovery despite adequate suppression of viral load. There are many patients using herbal supplements but there is limited scientific clinical evidence on the benefit of these supplements in HAART patients.

The persistence of an aberrant state of immune activation and inflammation (pIA) may contribute to the emergence of serious non-AIDS events which carry a higher morbimortality in HIV-infected patients. Although combined antiretroviral treatment (cART) reduces both cellular and soluble activation markers, it fails to completely control pIA despite consistent plasma viral load suppression. One of the mechanisms involved in pIA is may be an incomplete suppression of viral replication not reflected by plasma viral load, which only reflects a balance between viral replication and clearance of HIV-RNA. In addition, low-level viremia detected in most HIV-1-infected patients despite years on cART. Unintegrated 2-LTR HIV-DNA, and cellular associated HIV-RNAs, as products of active integrated DNA transcription, support this issue. Furthermore, the key rationales behind simplifying cART are a reduction of toxicities, lower risk of resistance mutations in case of virological failure and saving costs. One of these simplification strategies is a dual therapy which, based on the data up to date and in our clinical experience, has similar virological efficacy than cART. However, it is unknown if this strategy could increase the persistent HIV-1 replication and, therefore, pIA. The CD4+/CD8+ T cell ratio as a marker of immune recovery, the changes in T cell immune activation, senescence, exhaustion and apoptosis, and the cellular associated HIV-DNA and -RNA would answer the question if simplification to dual therapy would provide less control of residual HIV replication and, therefore, a detriment on pIA compared to triple therapy and, therefore, would worsen the patients' long-term prognosis.

This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects. The study will be carried out in two parts. Part 1 of the study will be open label, up to 3 periods design with a wash out period of at least 7 days between treatment periods. Subjects will be randomized to receive either single entities or formulation 1 FDC of DTG and 3TC in a crossover manner in first 2 periods. The first 16 subjects who complete the first two treatment periods and consent to continue will receive a single dose of FDC formulation 1 tablet administered with a high fat meal for a third treatment period. In Part 2 of the study, subjects will be randomized to receive either single entities or formulation 2 FDC of DTG and 3TC in a crossover manner in first 2 periods. Similarly the first 16 subjects will then receive FDC formulation 2 tablets with high fat meal in treatment period 3. Subjects will have a follow-up visit within 7-14 days after the last dose of study drug. Approximately 76 healthy subjects will be included in Part 1 of the study and if Part 2 of the study is conducted, another 76 healthy subjects will be included. The total duration will be approximately 11 weeks.

A phase IV, multicentre, randomised, open-label, pilot clinical trial designed to evaluate HIV-infected, aviremic patients who receive treatment with the combination of DTG/3TC/ABC and who have neuropsychiatric adverse effects that, in the opinion of the investigators, may be related to taking DTG/3TC/ABC, if they improve after switching antiretroviral therapy to the combination of ELV/COBI/FTC/TAF.

To study the safety and effectiveness of the combination of Chidamide with Chimeric Antigen Receptor(CAR)-T or T cell receptor(TCR)-T cell therapy on HIV patients based on cART.