View clinical trials related to HIV Infections.
Filter by:The purpose of this study is to evaluate the efficacy and safety of CABENUVA (Long-acting Cabotegravir Plus Long-acting Rilpivirine) in patients with HIV infection and severe renal impairment. This study is considered research and is voluntary.
This study will investigate the use of a next-generation Reader as part of a digital pill system (DPS; ID-Cap System) to measure adherence to both antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) in people living with HIV (PLWH) and HIV-negative individuals, respectively. During the first (non-human subjects) component of this study, we developed a wrist-borne Reader according to design specifications and preferences shared by DPS users from our previous studies. Early bench testing by etectRx (manufacturer of the ID-Cap System) demonstrated that the wrist-borne version of the Reader acquires signal from the digital pill. This study will therefore evaluate the usability of and user response to a wrist-borne Reader component of the DPS among PLWH on ART and HIV-negative individuals on PrEP.
In people infected with HIV, with suppressed HIV viral load and receiving treatment with DTG/3TC: The change to BIC/FTC/TAF will decrease the development of adverse events of neuropsychiatric etiology. The change to BIC/FTC/TAF may improve the patient´s tolerability and degree of acceptance and use of TAR.
A prospective interventional study to evaluate a strategy of point-of-care testing for sexually transmitted infections including chlamydia, gonorrhoea, trichomoniasis, syphilis, and Hepatitis B with comprehensive case management including partner notification in antenatal settings in Harare province, Zimbabwe.
Uganda uses a threshold of 1,000 copies/ml to determine HIV viral non-suppression among people living with HIV/AIDS (PLHIV) on treatment, which is indicative of either poor adherence or HIV virologic treatment failure; as per the recent WHO recommendations. The use of this high threshold of 1,000 copies/ml has resulted into an increase in the number of PLHIV having low-level viraemia (≥50 to <1,000 copies/ml) from 11.0% in 2017 to 35.0% in 2020 in Uganda. Different studies in developed countries have shown that low-level viraemia is associated with HIV drug resistance, and despite this, there is no intervention to manage and control low-level viraemia (LLV), as per the recent Uganda national HIV guidelines. With this increasing and unmanaged low-level viraemia (LLV), Uganda might never achieve the global targets of ending AIDS as epidemic by 2030, as stipulated by target 3.3 of SDG 3. This study will therefore determine the effectiveness of intensive adherence counselling on achieving a non-detectable viral load (below 50 copies/ml) in the management of LLV among PLHIV on ART in Uganda. This study will generate useful information that might guide the review of the national HIV guidelines, to control and manage LLV among PLHIV on ART; and thereby enable Uganda to achieve the global goals of SDG 3, Target 3.3 and the national targets of Vision 2040.
This study will evaluate the implementation of an enhanced package of care, CD4 and tuberculosis lipoarabinomannan (TB-LAM) tests and the initiation of patients on TB prophylaxis [TPT and CPT], on retention in care and viral suppression ((<50 copies/ml) at 6 and 12 months after AHD care and treatment enrollment. The study will also assess the change in AHD screening, management and service uptake indicators among PLHIV clients before and after implementation of the QI collaborative implementation (QICI) project, evaluate the acceptability and feasibility of the AHD package of care among patients and HCWs providing related health services, and conduct a cost analysis of implementing the enhanced AHD package of care in a hub-and-spoke implementation of care model.
Integrase-strand-transfer-inhibitors (INSTIs) based regimens have been associated with body weight gain and increase in total body adipose tissue (AT). Whereas there is by now no clear understanding of the mechanisms that induce these changes, we have observed modifications of AT in vitro, in animals models or in vivo in obese patients with raltegravir (RAL) and dolutegravir (DTG) with the presence of increased peri-adipocyte fibrosis and high levels of collagen VI that have been associated with poor metabolic prognoses together with cellular insulin resistance and decreased adiponectin secretion. One major clinical question is whether such AT abnormalities are reversible. Doravirine (DOR), the most recent available Non-Nucleosidic Reverse Transcriptase Inhibitor (NNRTI) drug, has an excellent metabolic profile and as a NNRTI is expected to induce neither changes in fat tissue distribution nor changes in body weight. Tenofovir disoproxil fumarate (TDF) is associated with a protective lipid profile and, unlike tenofovir alafenamide (TAF) which seems to potentiate weight gain in combination with INSTI, has not been associated with weight gain. One major clinical question is whether such AT abnormalities are reversible. Doravirine, the most recent available NNRTI drug, has an excellent metabolic profile and as a NNRTI is expected to induce neither changes in fat tissue distribution nor changes in body weight. Tenofovir DF is associated with a protective lipid profile and, unlike TAF which seems to potentiate weight gain in combination with INSTI, has not been associated with weight gain. We hypothesized that modifications in morphology and function of the adipose tissue in patients with significant weight gain under an INSTI-based regimen could be improved after switching to the triple drug TDF/Emtricitabine/DOR and that fat increase and body weight will be stopped or reversed. This pathogenesis study aimed to evaluate potential changes in adipose tissue after switching from an INSTI-based regimen (Raltegravir or Dolutegravir or Bictegravir) to TDF/Emtricitabine/DOR. Each patient will be evaluated with an adipose tissue biopsy performed before (D0) and after a 48 week switch (W48) from an INSTI-based regimen to the non INSTI-based regimen combining TDF/3TC/Doravirine. With a number of 22 patients at D0, a total of 20 patients with paired adipose tissue biopsies are expected at W48. The antiretroviral therapy with TDF/emtricitabine/Doravirine will be used as routine practice recommends.
SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS) disease, in a routine primary and secondary care setting in southern Africa with regard to HIV viral suppression (VL <400 copies/mL) 26 weeks after enrolment.
A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 inserted every 30 days and 100 mg Dapivirine Vaginal Ring-008 inserted for 90 days in Healthy Female Participants
Implementation of a model for access and retention of HIV care for vulnerable and excluded population using a mobile screening unit and a strategy of diagnosis and initiation of treatment with Bictegravir (BIC) 50 mg/ Emtricitabine (FTC) 200 mg / Tenofovir Alafenamide (TAF) 25 mg.