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NCT ID: NCT06005610 Recruiting - HIV I Infection Clinical Trials

Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy

GET IT RIgHT
Start date: January 4, 2024
Phase: Phase 2
Study type: Interventional

Transgender women (TW) are a key population and priority for HIV treatment. More research is needed to develop evidence-based clinical guidance when it comes to choosing antiretroviral treatment (ART) regimens for TW on feminizing hormonal therapy (FHT). Concerns about ART interacting with FHT and decreasing its effectiveness can lead to decreased ART adherence and increased viral loads. The GET IT RiGHT trial aims to address concerns about drug-drug interactions (DDIs) between ART and FHT while providing access to hormonal therapy to TW living with HIV. Data suggest that access to FHT improves adherence to HIV treatment and decreases treatment interruptions. This is an open-label, non-randomized, 3-group trial of adult TW and other individuals identifying as female or transfeminine but with male sex assigned at birth living with HIV. Participants will be on ART at entry and receive study-supplied 17-β estradiol for FHT for 48 weeks. The primary objectives of the study are to 1) assess whether TW continue to achieve therapeutic concentrations of ART while receiving FHT for 48 weeks and 2) assess whether serum estradiol concentrations on FHT (across a range of estradiol doses) vary between boosted and un-boosted ART regimens.

NCT ID: NCT05986084 Recruiting - Breast Feeding Clinical Trials

Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana

Tshireletso
Start date: November 30, 2023
Phase: Phase 4
Study type: Interventional

The goal of this this hybrid safety/implementation study is to evaluate whether using long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe in post-partum people who are breastfeeding. The main question[s] it aims to answer are: - Will CAB-LA injections work well as a way to prevent HIV infection in post-partum people? - Will CAB-LA injections be safe in post-partum people and their infants who will be breastfeeding? Participants without HIV who are admitted to the maternity ward after having delivered a baby will be offered to start CAB-LA PrEP. Those who choose to participate will receive their first dose (injection) at the maternity ward and their follow up doses (injections) at their local clinic when they come for routine post-partum and pediatric care. Participants and their infants will be followed in the study for 24 months. We will be following how many people come on-time for their CAB-LA injections, how often they keep coming back, and the reasons they continue (or stop) these injections. We will also test people for HIV at all of their visits to see how many people get HIV during the study. We will also measure the levels of the medication in the blood of the post-partum people and their infants (who may be getting some of the CAB-LA in breastmilk) and evaluate to see if their is any impact of CAB-LA on the health of the post-partum person or their infants.

NCT ID: NCT05952141 Recruiting - Cervical Cancer Clinical Trials

Strategies to Close the Gap From CC Diagnosis to Treatment in Botswana

Start date: September 18, 2023
Phase: N/A
Study type: Interventional

Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.

NCT ID: NCT05660980 Recruiting - HIV-1-infection Clinical Trials

Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age

Start date: January 24, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age

NCT ID: NCT05605951 Recruiting - Multiple Sclerosis Clinical Trials

Acute Optic Neuritis Network: an International Study That Invesitages Subjects With a First-ever Episode of Acute Inflammation of the Optic Nerve

ACON
Start date: August 15, 2020
Phase:
Study type: Observational

The goal of this observational study is to longitudinally investigating subjects with inaugural acute optic neuritis (ON). The main questions it aims to answer are: - Does the time to corticosteroid treatment affect the visual outcome at 6 months in subjects with acute multiple sclerosis (MS)-, aquaporin 4-IgG positive (AQP4-IgG+) and myelin-oligodendrocyte-glycoprotein-IgG positive (MOG-IgG+) ON? - How differ clinical, structural, and laboratory biomarkers in subjects with acute ON, including clinical isolated syndrome (CIS), MS-ON, AQP4-IgG+ON, MOG-IgG+ON and seronegative non-MS-ON? Participants will undergo - clinical examination, including clinical history, neurovisual and neurological tests - serum and cerebrospinal fluid examination - optical coherence tomography (OCT) - magnetic resonance imaging (MRI) - assessment of depression, pain, quality of life through validated questionnaires Researchers will compare subjects with MS-ON, AQP4-IgG+ON, MOG-IgG+ON and other ON (CIS, seronegative non-MS-ON) to detect diagnostic and predictive markers for the disease course.

NCT ID: NCT05580666 Recruiting - Clinical trials for HIV Disease Progression

Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

REVIVE
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.

NCT ID: NCT05551273 Recruiting - HIV Infections Clinical Trials

Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV

Start date: May 5, 2023
Phase: Phase 2
Study type: Interventional

The study aims to assess safety and tolerability of oral toll-like receptor (TLR) 8 agonist Selgantolimod (SLGN) administered for 24 weeks in participants with both CHB and HIV who have been receiving suppressive antiviral therapy for both viruses for ≥5 years and have qHBsAg level >1000 (3 log10) IU/mL at screening. The study will also evaluate if TLR8 stimulation with SLGN will reduce hepatitis B surface antigen (HBsAg) titers in the blood.

NCT ID: NCT05414526 Recruiting - Hypertension Clinical Trials

Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE)

InterCARE
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

The InterCARE research project proposes to leverage a successful national ART program to develop an effective package to improve the uptake of established effective hypertension and CVD risk factors management interventions among PLWHIV in Botswana and other low- and middle-income countries. Being the first project of its kind in Botswana, if successful, the InterCARE package could be readily rolled out to health facilities nationwide to diagnose, treat, track, and support the estimated 25-30% Batswana with hypertension.

NCT ID: NCT05393193 Recruiting - HIV Clinical Trials

Point-of-Care HIV Testing and Early Dolutegravir Use for Infants

Moso
Start date: July 4, 2022
Phase: Phase 4
Study type: Interventional

This study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. Infants found to be HIV infected will be immediately offered enrollment into a dolutegravir (DTG) antiretroviral treatment study cohort (if maternal consent is granted) or referred for treatment at a government facility. Infants who enter the study treatment cohort will be prospectively followed through 96 weeks of age. ART will follow Botswana guidelines.

NCT ID: NCT05154513 Recruiting - HIV Infection Clinical Trials

Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV

Start date: February 2, 2022
Phase:
Study type: Observational

IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure. Up to approximately 250 participants will be in the study for approximately seven years. No intervention is provided in the study.