View clinical trials related to HIV-1 Infection.
Filter by:The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (DOR 100mg) and islatravir (ISL 0.75mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.
This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.
The HIV epidemic in Peru remains concentrated in the subpopulation of men who have sex with men (MSM), where the prevalence of disease has been estimated between 10-22% in recent epidemiologic surveys. Partner-based methods to limit the spread of HIV and STI co-infection, including partner notification and partner treatment, provide an important new strategy for HIV control in the region. Expedited Partner Therapy (EPT) has been shown to reduce rates of persistent or recurrent gonorrhea and chlamydia infection in heterosexual patients, but has not been fully evaluated for use among men who have sex with men (MSM). CDC guidelines support the use of EPT for partner management with heterosexual patients, but note the absence of evidence necessary to make an equivalent recommendation for the use of EPT with MSM. Randomized clinical trials to assess the impact of EPT on partner notification, treatment, and STI re-infection among MSM are critical to the development of evidence-based partner management guidelines. As a theoretical model, EPT integrates behavioral, social, and biomedical approaches to HIV/STI control in a comprehensive prevention intervention. Our proposed exploration of the social and behavioral dimensions of partner notification and treatment will provide a methodological structure for understanding the influence of EPT on behavioral decision-making processes, interpersonal factors that influence partner notification, and network patterns of STI transmission within MSM populations in Peru. The proposed study includes a screening protocol to identify eligible MSM subjects for participation in our planned study of the effect of EPT on partner notification, treatment, and linkage to HIV prevention and care services. Potential participants will complete a behavioral survey and undergo physical examination and testing for HIV, syphilis, gonorrhea, and chlamydia. Participants diagnosed with Gonorrhea and/or Chlamydia (at any anatomic site) will be eligible for enrollment in our Partner Management study of EPT and the HIV prevention cascade among MSM in Peru. Participants in the Partner Management study will be randomly assigned to receive either standard of care partner notification counseling or standard counseling along with a maximum of five antibiotic treatment packets to deliver to their recent sexual partners. Participants will be asked to return to the site after 21 days to report on their actual partner notification behavior, with differences in notification evaluated between the two groups. Participants will then work with a study counselor to identify their recent partners and, if the participant agrees, to provide contact information so that the study team can contact these partners. Study staff will either confirm that the partner has already been notified, or provide notification of their likely STI exposure. After informing partners of their STI exposure, staff will ask partners to provide verbal consent to a single question evaluation (whether or not the partner had previously been informed of their exposure) to verify participant-reported behavior. Partners will also be asked to visit the study site to complete a brief survey of their sexual practices and treatment-seeking behavior, as well as to undergo testing for HIV and STIs. All of the above data will be used to construct models of the spread of HIV and STIs in local MSM networks, and the potential effect of EPT on controlling the spread of STIs in this population.
HIV-CORE 006 is a Phase 1 double-blind placebo-controlled trial, in which the mosaic immunogens are delivered by a prime-boost regimen of non-replicating simian adenovirus followed by non-replicating poxvirus MVA. Volunteers will be randomised to receive either the vaccine regimen or placebo at 2 vaccination visits 4 weeks apart. The vaccine regimen consists of a single mosaic prime ChAdOx1.tHIVconsv1 (C1) and a dual boost of MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) administered simultaneously. The trial will recruit healthy African adults 18-50 years of age, who are HIV-uninfected and at low risk of HIV infection. The trial is designed to enrol 88 healthy men and women, who will be randomised to receive either the vaccine regimen or placebo in a ratio of 72:16: - Vaccine Arm (ChAdOx1.tHIVconsv1 prime followed by MVA.tHIVconsv3 and MVA.tHIVconsv4 boost at 4 weeks after enrolment); 72 vaccine recipients; - Placebo Arm; 16 recipients To maintain blinding, all volunteers will receive two injections with half dose into the deltoid region of each arm of ChAdOx1.tHIVconsv1 or placebo at enrolment, and two injections (MVA.tHIVconsv3 or placebo into one deltoid region and MVA.tHIVconsv4 or placebo into the other) at 4 weeks after enrolment. The primary goal of assessing safety and immunogenicity will be served by weighting the randomisation toward vaccinees.
CORIA is an observational cohort study of immunosuppressed populations who test positive for COVID-19. This includes people living with HIV, cancer, acquired immunodeficiency associated with other immunosuppressive therapy, primary immunodeficiency and recipients of a solid organ transplant. Participants will have routine clinical data collected with optional baseline collection and storage of a blood sample for storage . The study will be conducted in up to 30 sites within Australia.
The efficacy and safety of Biktarvy in Treatment-Naïve Late Presenters with HIV-1 Infection
Impact of Rapid ART Initiation on Retention in Care in the Southern US Specific Goals and Aims: The major goal for this study is to determine if rapid start of antiretroviral (ART) therapy increases retention in HIV medical care. The investigators hypothesize that there will be an increase in retention in care with rapid start, by removing barriers that would normally delay enrollment in a treatment program and enforce the importance of linkage to care and ART initiation from diagnosis. In order to test this hypothesis, the investigators have the following specific aims for their proposed study: 1. Study retention in care after rapid ART start in comparison to standard of care. 2. Analyze risk factors for decreased retention in care, with focus on high-risk populations. 3. Analyze potential demographic and geographic determinants of retention in care. 4. Generate retention in care data in a Southern US state. The investigators hypothesize the introduction of rapid start ART, as well as the introduction of care navigators, will lead to improved clinical outcomes, including retention in care at one year, viral suppression at one year, time to viral suppression, and time to first missed appointment. In the event rapid start ART fails to have a positive impact on clinical outcomes, the results of this study will still positively contribute to the knowledge gap, since there is a scarcity of data in the Southern United States, specifically in high-risk populations, such as racial and ethnic minorities, youth, and patients co-infected with hepatitis C.
This is a randomized, double-blinded, placebo-controlled Phase III interventional trial of the nine-valent HPV vaccine (9vHPV) to prevent persistent oral HPV infection in adult cisgender men and transgender women living with HIV.
This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.
This is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetics of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and 10-1074-LS-J which targets the V3 loop of HIV-1 envelope protein. The hypothesis is that the two antibodies will be safe for healthy HIV-1 uninfected adults when co-administered subcutaneously or intravenously and, after subcutaneous administration in the optimal ratio, each antibody will maintain serum levels >10 µg/ml for at least 3 months in HIV-uninfected participants.