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HIV Infections clinical trials

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NCT ID: NCT04853394 Completed - HIV Infections Clinical Trials

Tajik Migrant Health Education Study

Start date: October 19, 2021
Phase: N/A
Study type: Interventional

This study will test the efficacy of a peer-education prevention intervention to reduce risky drug, alcohol, and sexual behaviors among male Tajik labor migrants who inject drugs (MWID) while working in Moscow. The peer educator intervention will be compared to a health education control intervention. Each intervention consists of 5 weekly 2-hour small group sessions. Follow-up assessments will be conducted at 3, 6, 9, and 12 months after the intervention. It is hypothesized that, compared to MWID who receive the health education control intervention, those who receive the peer educator intervention will have a greater reduction in the frequency of risk behaviors. Similar effects are expected for network members of intervention participants.

NCT ID: NCT04847388 Completed - HIV Infections Clinical Trials

Prevalence of Substance Abuse Among Anti-retroviral Treatment Naive Patients Positive for HIV Antibodies

Start date: April 1, 2021
Phase:
Study type: Observational

Individuals utilise substances to elevate their mood. Alcohol, cannabis, nicotine, cocaine, and methamphetamine are examples of substances. Excessive usage of a drug that is harmful to oneself and society is referred to as substance addiction/abuse. People who inject drugs and share needles, as well as drugs that impair judgement and lead to unprotected intercourse with an infected partner, have been related to risky sex behaviour and unsafe sex, both of which increase the risk of HIV infection. Several factors, including immunologic and virologic conditions affecting host susceptibility, underlying comorbidities among drug users, use of antiretroviral therapy, and viral strain, as well as pharmacodynamic aspects of drug use, such as the pattern and type of drug administration and the route of administration, may mediate the relationship between drug use and HIV disease progression. Exacerbation of HIV progression has been shown in patients with substance addiction in laboratory research.

NCT ID: NCT04840199 Completed - HIV Infections Clinical Trials

A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.

ELICIT
Start date: November 2, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label, controlled study, conducted at US sites to evaluate the anti-inflammatory effectiveness of the study drug letermovir in adults with HIV and asymptomatic cytomegalovirus (CMV) who are on antiretroviral therapy (ART)-mediated suppression. Participants will be randomly assigned to receive either letermovir once daily or no anti-CMV treatment, for 48 weeks.

NCT ID: NCT04836091 Completed - HIV/AIDS Clinical Trials

Acceptability, Feasibility and Preliminary Impact of OurPlan, an mHealth HIV Prevention Intervention for Male Couples

OurPlan
Start date: March 16, 2021
Phase: N/A
Study type: Interventional

The study will evaluate the use and preliminary impact of an mHealth app for improving sexual health outcome measures among male couples by assessing whether exposure and use of the app results in improvements in participants and couples' self-reported sexual health and prevention behaviors, beliefs, and attitudes. The study will enroll both men of the couple into a randomized controlled trial. Participants/couples randomized to the intervention will have access to the app for two months while those assigned to the waitlist group will receive and have access to the app for one month. Participants will complete surveys at baseline and at month 2.

NCT ID: NCT04827134 Completed - HIV Infections Clinical Trials

A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants

Start date: May 7, 2021
Phase: Phase 1
Study type: Interventional

This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir [DTG] 5 milligrams [mg]/abacavir [ABC] 60 mg/lamivudine [3TC] 30 mg) dispersible tablets and DOVATO (DTG 5 mg/3TC 30 mg) dispersible tablets in healthy adult participants. Additionally, safety and tolerability of these formulations will also be assessed. TRIUMEQ and DOVATO are registered trademarks of GlaxoSmithKline group of companies.

NCT ID: NCT04826094 Completed - HIV Infections Clinical Trials

A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya

Start date: March 15, 2021
Phase: Phase 1
Study type: Interventional

This is a study of HIV vaccines. A vaccine is a medical product given to prevent certain diseases. The vaccine may educate the body to form a defensive response to try to prevent the disease from the beginning, or preventing it from taking hold of the body. This defensive response is called the immune response. The experimental vaccines in this study are Env-C Plasmid DNA and HIV Env gp145 C690 protein, given with different adjuvants. An adjuvant is a substance added to vaccines that can help make the vaccine more effective by improving the immune response, or by causing the immune response to last longer than it would without the adjuvant. The adjuvants are mixed with the vaccines and injected into muscle or placed on top of the skin. The HIV vaccines contain a piece of genetic material or a protein copied drom the HIV virus cover (Env), but they do not contain the virus itself. The vaccines cannot cause HIV infection or Acquired Immune Deficiency Syndrome (AIDS). The purpose of this study is to find out if the study vaccines with adjuvants cause side effects and are tolerable, whether humans respond (develop immune responses) to the vaccines, and how ling the effects of the study vaccines last. The study will also compare the effects of the study vaccines with adjuvants and adjuvant patch to those of placebo injections and placebo patch. The placebo will consist of saline (sterile saltwater) and will look like study vaccines, be given in the same way, but will have no active vaccine or adjuvant in it. A total of 126 participants will take part in the study and each will have up to 26 clinic visits and will be followed-up for a total of 108 weeks.

NCT ID: NCT04824131 Completed - HIV Infections Clinical Trials

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females - A Sub-study of HPTN 084

Start date: November 4, 2020
Phase: Phase 2
Study type: Interventional

This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.

NCT ID: NCT04813484 Completed - HIV Infections Clinical Trials

Addressing Violence and HIV Care Among Transgender Women

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

This project seeks to adapt and pilot a trauma-informed combination intervention named 'Kickin' it with the Gurlz' that was designed with, for, and by transgender women of color to improve HIV care continuum outcomes. The intervention components include a violence and gender affirmation screening tool, a peer-led adaptation of Seeking Safety, and individual-level peer navigation sessions. The project will examine the feasibility, acceptability, and preliminary promise of the multicomponent by conducting a one-arm pilot with 30 transgender women of color who have a history of trauma. Participants will complete baseline, immediate post-intervention, and 3-month follow up assessments.

NCT ID: NCT04811040 Completed - HIV-1 Infection Clinical Trials

Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection

Start date: April 8, 2021
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872) in combination with the HIV capsid inhibitor lenacapavir (LEN).

NCT ID: NCT04808973 Completed - HIV Infections Clinical Trials

DTG Plus 3TC for Prophylaxis of Mother-to-child Transmission of HIV Infection in Pregnant Women

PREGNANCY
Start date: July 1, 2021
Phase: Phase 3
Study type: Interventional

The study aims to evaluate the safety and efficacy of a 2 drugs ART regimen (lamivudine plus dolutegravir) for prevention of mother to child transmission in pregnant women with HIV. 20 pregnant women will be enrolled in this proof of concept protocol. They will be prescribed DTG-3TC (fixed-dose combination), and will be followed up to the end of gestation. Initially, a total of 10 pregnant women will be recruited for the first phase of the study. Once the first phase is successfully completed, 10 additional participants will be included in a second step.