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Human Immunodeficiency Virus clinical trials

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NCT ID: NCT04944654 Terminated - Clinical trials for Human Immunodeficiency Virus

Efficacy, Tolerability and Acceptability of Biktarvy by TPLWH

Start date: January 7, 2023
Phase: Phase 4
Study type: Interventional

This is a clinical trial for TPLWH (Trans People Living with HIV) who are stable on cART with an undetectable viral load or a detectable viral load but no resistance to NRTIs and InSTI. Following written consent and screening procedures, study subjects will undergo a switch (or will restart) of their combination antiretroviral therapy (cART) to Biktarvy. The goal of this research project is to recruit an understudied population into a controlled clinical trial aimed at optimizing TPLWH cART. This will be demonstrated by measuring viral load outcomes at regular intervals, with a focus on viral load results 48 weeks after Biktarvy initiation (primary outcome).

NCT ID: NCT04240210 Terminated - Clinical trials for Human Immunodeficiency Virus

Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)

SymITA
Start date: September 17, 2019
Phase: Phase 4
Study type: Interventional

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/COB/FTC/TAF) is a coformulated STR, is the only protease inhibitor based STR, and is noted for its high tolerability3. These traits have the potential to improve adherence in patients who have intolerance to the integrase inhibitor class. We propose a two part study design to evaluate if patients who have suboptimal adherence due to integrase inhibitor intolerance may better tolerate Symtuza and subsequently have improved adherence.

NCT ID: NCT03742375 Terminated - Clinical trials for Human Immunodeficiency Virus

Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients

GAIN
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

The pathophysiology from anal HPV infection to Anal Intraepithelial Neoplasia is less well understood than cervical HPV infection. In cervical screening programs it is well accepted that the sole presence of a high-risk HPV strain (irrespective of number of viral particles) is sufficient to justify further investigation and treatment. The investigators hypothesize that in anal HPV infection not only the presence but the extent of HPV infection (single genotype viral load) or combination of different HPV genotypes (cumulative viral load) is of importance in determining the risk of anal dysplasia.

NCT ID: NCT03516318 Terminated - Clinical trials for Human Immunodeficiency Virus

Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria

Y-SMART
Start date: September 4, 2018
Phase: N/A
Study type: Interventional

A randomized control trial to test the effectiveness of a structured online support group, SMART (Social Media to improve ART Retention in Treatment) Connections, to improve retention in HIV care services among youth living with HIV (YLHIV) in Nigeria.

NCT ID: NCT03489109 Terminated - Metabolic Syndrome Clinical Trials

2-5 Intermittent Caloric Restriction in HIV

2-5toWIN
Start date: May 9, 2018
Phase: N/A
Study type: Interventional

Background: Weight gain can lead to obesity and diabetes even in people living with human immunodeficiency virus (HIV). Researchers want to see if the technique intermittent calorie restriction can help overweight people with HIV as an alternative to traditional diets. Objective: To see if intermittent calorie restriction leads to weight loss and improved blood sugar in obese people with HIV. Eligibility: Adults ages 18-65 with HIV who are obese and do not have diabetes Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. Before starting treatment, participants will: - Have a nutritional consultation - Get a pedometer to record daily steps - Test a restricted diet for 1 day - Have a body x-ray At the baseline visit, participants will have: - Blood drawn after they drink a sugar drink - Questions about their health and eating - A nutritional consultation - Resting energy expenditure measured. Participants will fast overnight. Then they will lie down while a plastic bubble goes over the head and a plastic sheet covers the upper body. Oxygen flows into the bubble. - Liver stiffness test. A wand on the stomach releases sound waves like an ultrasound. For 12 weeks, some participants will be on a standard diet. Others will restrict how much food they eat 2 days a week. On those days they will eat about 25% of their recommended calories. Participants will keep a diary of their diet and steps. Participants will have 4 visits during the 12-week diet and 1 visit 12 weeks after the diet ends. They will repeat previous tests.

NCT ID: NCT03221582 Terminated - Hepatitis C Clinical Trials

Impact of Hepatitis C Therapy and Bone Health

HCV
Start date: August 28, 2017
Phase: Phase 4
Study type: Interventional

An evaluation of the impact of Elbasvir and Grazoprevir (EBR/GZR) HCV therapy on the heart risk and bone health of HCV mono-infected and HIV/HCV co-infected patients.

NCT ID: NCT03110549 Terminated - Clinical trials for Human Immunodeficiency Virus

Study of the Safety, Tolerability and Pharmacokinetics of TMB-607 in HIV-Negative Volunteers

Start date: November 21, 2016
Phase: Phase 1
Study type: Interventional

The study is a Phase 1, randomized, double-blinded, placebo-controlled, sequential single dose escalation safety, tolerability and pharmacokinetic study of subcutaneous and intramuscular TMB-607 administered to HIV-negative volunteers.

NCT ID: NCT02531295 Terminated - HIV Clinical Trials

Immunologic Response to Kansui in Treated HIV+ Individuals: a Dose Escalation Study

Start date: May 15, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and bioactivity of an herbal supplement called "kansui," which contains several active ingredients such as ingenols that may have a role in helping clear HIV from the body. Kansui has been used in traditional Chinese medicine for centuries to treat various ailments such as for eliminating excess fluid in the abdomen or lungs, loosening phlegm from the chest, and relieving constipation. Based on preliminary in vitro data from our group, kansui extract powder is a potent activator of HIV transpcription in latently infected Jurkat cells. The investigators' hypothesis is that kansui extract powder prepared as tea will be safe and well-tolerated, elicit an in vivo immunologic response, and at the doses administered, increase HIV transcription in latently-infected cells among HIV-infected patients on suppressive antiretroviral therapy.

NCT ID: NCT02338141 Terminated - Cervical Cancer Clinical Trials

Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women

Start date: August 2015
Phase: N/A
Study type: Interventional

This study will evaluate the effectiveness of portable colposcopy when compared to conventional colposcopy (25x magnification of the cervix, the gold standard) and Visualization Inspection with Acetic acid (VIA, with 1x magnification, the accepted low-resource method). Half the participants will be evaluated for cervical pathology by portable colposcopy after VIA assessment, while the other half will be evaluated by conventional colposcopy. This study also will use collected lab specimens for human papillomavirus (HPV)-positive women to determine those HPV genotypes most prevalent among higher grade disease cases (CIN II+) and among the sub-group of human immunodeficiency virus (HIV)-positive women.

NCT ID: NCT01814722 Terminated - Clinical trials for Human Immunodeficiency Virus

Quality of Life of HIV-infected Participants Switched to Raltegravir Versus Other Antiretroviral Regimens (MK-0518-266)

Start date: November 2012
Phase: N/A
Study type: Observational

This is a multi-center, longitudinal observational study of adult human immunodeficiency virus (HIV) participants at academic and community-based practices in the United States who are switching from first-line to second-line therapy. The study's primary hypothesis is that HIV participants switching to raltegravir-based regimens will have better Medical Outcomes Study-HIV (MOS-HIV) Health Survey scores than participants switched to non-nucleoside reverse transcriptase inhibitor (NNRTI)-based or protease inhibitor (PI)-based regimens.