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HIV/AIDS clinical trials

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NCT ID: NCT04405700 Recruiting - Pregnancy Related Clinical Trials

Measuring Adverse Pregnancy and Newborn Congenital Outcomes

MANGO
Start date: September 29, 2020
Phase:
Study type: Observational

The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).

NCT ID: NCT04401670 Completed - Cervical Cancer Clinical Trials

Cervical Cancer Screening in Cameroon

Start date: April 25, 2017
Phase: N/A
Study type: Interventional

Human immunodeficiency virus-infected (HIV[+]) women have a several-fold increased risk of invasive cervical cancer (ICC) as well as increased risk of cervical pre-cancer. In low- and middle-income countries (LMICs), ICC is the 1st or 2nd most common cause of cancer and cancer-related death in women. Rates of ICC and ICC-related mortality are particularly high in Sub-Saharan Africa, which also has the highest rates of HIV infection in the world. Although prophylactic HPV vaccines may be the optimal cervical cancer prevention strategy, 2-3 generations of at-risk HIV[+] and HIV[-] women are already highly exposed to human papillomavirus (HPV) and would not benefit from (and will not be immunized with) HPV vaccine. Thus cervical cancer screening is needed for the foreseeable future. However, Pap testing is expensive and requires a complex clinical and lab infrastructure that does not generally exist in LMICs; strategies based on high-risk HPV (hrHPV) testing or visual inspection after acetic acid (VIA) are promising but are either too non-specific, leading to over-referral for colposcopy or over-treatment, or are too insensitive, respectively. Thus, inexpensive, easily implemented, and effective cervical cancer screening methods are greatly needed in Sub-Saharan Africa, especially for HIV[+] women. This cervical cancer screening study of 1,200 women (800 HIV[+] and 400 HIV[-] women), aged 25-59 years, living in Cameroon, utilized our existing research site. The investigators evaluated screening tests (hrHPV testing, VIA and Pap), traditional triage tests (HPV16/18/45 detection, VIA, Pap), and promising new biomarkers for triage (Ki-C67, TOP2a, CDKN2A, and HPV viral load) of screen-positive women. All screen positives underwent rigorous disease ascertainment to obtain unbiased estimates of sensitivity, specificity, and positive and negative predictive value. The goal of this study was to establish the foundation and capacity for future studies designed to reduce the burden of HPV-associated cancers in the Cameroon population. It will inform Cameroon and other countries with high HIV burdens on the best strategies for cervical cancer screening in their HIV[+] and HIV[-] women.

NCT ID: NCT04396678 Completed - HIV/AIDS Clinical Trials

Developing a PrEP Adherence Intervention Targeting At-Risk and Substance Using Women

PEARL
Start date: June 12, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy on adherence of a community-informed intervention for tenofovir/emtricitabine (TDF/FTC) pre-exposure prophylaxis (PrEP) engagement among street-based female sex workers (FSW) in Baltimore, Maryland.

NCT ID: NCT04385719 Completed - HIV/AIDS Clinical Trials

Drug-drug Interactions Between Remdesivir and Commonly Used Antiretroviral Therapy

RemTLAR
Start date: May 5, 2021
Phase: Phase 2
Study type: Interventional

Ebola and HIV are found predominately in the same regions of the world and countries in sub-Saharan Africa are most affected by both diseases. For Ebola, no approved therapies exist. However, new investigational drugs are being evaluated to understand if they are effective against the Ebola virus. Remdesivir is an anti-Ebola investigational drug for the treatment of Ebola. Little is known about how the blood levels of remdesivir relate to how effective it is in patients with HIV taking antiretroviral therapy. This study will explore how commonly utilized ART (tenofovir/lamivudine and atazanavir/ritonavir) affect the drug levels of remdesivir.

NCT ID: NCT04378439 Recruiting - HIV/AIDS Clinical Trials

Appalachian Partnership to Reduce Disparities (Aim 2)

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

By combining two strategies (i.e., peer navigation and mHealth) into a complete, culturally compatible, bilingual intervention to increase the use of needed HIV, STI, and HCV prevention and care services among racially/ethnically diverse GBMSM and transgender women in rural Appalachia. Study Investigators anticipate that participants in the intervention group, relative to counterparts in the delayed-intervention group, will demonstrate increased HIV, STI, and HCV testing.

NCT ID: NCT04372667 Completed - HIV/AIDS Clinical Trials

Adaptation and Evaluation of the PMTCT CSC in Dedza and Ntcheu Districts, Malawi

Start date: June 7, 2017
Phase: N/A
Study type: Interventional

This CDC-funded study sought to evaluate the effect of an adapted Community Score Card Approach on maternal retention in ART, maternal retention across the PMTCT service cascade, and the uptake of early infant diagnosis services in Malawi. The study also estimated the cost of the implementation of the Community Score Card Approach.

NCT ID: NCT04364165 Completed - HIV/AIDS Clinical Trials

Effect of U=U Messaging on HIV in South Africa

U=U
Start date: March 2, 2020
Phase: N/A
Study type: Interventional

This cluster randomized trial will investigate whether messaging about being undetectable equals untransmittable (U=U) designed through a participatory, user-centered approach increases HIV testing uptake within men in Klipfontein Mitchells Plain (KMP) district in Cape Town, South Africa.

NCT ID: NCT04364035 Completed - HIV/AIDS Clinical Trials

Safety, Tolerability and Immunogenicity of MVA.HTI and ChAdOx1.HTI With Vesatolimod in HIV-1 Positive Patients

AELIX-003
Start date: February 20, 2020
Phase: Phase 2
Study type: Interventional

AELIX-003 study aims to investigate the safety, tolerability, immunogenicity and efficacy of a regimen containing AELIX Therapeutics' HTI T-cell vaccines and Gilead´s Toll-Like Receptor 7 (TLR7) agonist vesatolimod in HIV-infected individuals on antiretroviral therapy. Study that will be conducted in 57 participants who have started antiretroviral therapy during early HIV infection, enrolled at various clinical trial sites in Spain. All participants will be on antiretroviral therapy upon starting the study, with their HIV viral loads <50 copies/mL. Following exposure to the vaccine/vesatolimod, all participants, under careful monitoring, will temporarily stop their antiretroviral drugs to determine if the intervention is effective in keeping their HIV levels under control.

NCT ID: NCT04359186 Recruiting - HIV/AIDS Clinical Trials

SCOPE Analytic Treatment Interruption Protocol

SCOPE-ATI
Start date: October 15, 2020
Phase: N/A
Study type: Interventional

The goal of this study is to understand the interaction between HIV and the host at the earliest stages when HIV medications are paused. Volunteers with HIV will interrupt antiretroviral therapy (ART) and then have intensive studies preformed two to three times per week. Most will resume therapy within three weeks, even if the virus does not rebound during this time.

NCT ID: NCT04357821 Active, not recruiting - HIV/AIDS Clinical Trials

Combinatorial Therapy to Induce an HIV Remission

Start date: August 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Combination approaches will almost certainly be required to generate durable control of HIV in the absence of antiretroviral therapy (a "remission"). In this study, 20 individuals will receive a combination regimen administered during ART and then undergo an analytic treatment interruption (ATI).