Active clinical trials for "Acquired Immunodeficiency Syndrome"

The study will test the feasibility and acceptability of using text messages and behavioral economics-based incentives to support anchoring Anti-Retroviral Therapy (ART) adherence to an existing routine in order to improve long-term ART medication adherence. The intervention phase of the three-phased study will constitute the pilot RCT. A sample of 150 clients who have initiated ART in the preceding three months will be randomized to either usual care (C = 50) or one of the two INMIND intervention groups (daily text message reminders with or without incentives) for three months (T1 = 50; T2=50). Subsequently, behavioral persistence will be evaluated for six months post-intervention. Assessments will be conducted at baseline, month 3, and month 9. The primary outcomes are 1) electronically measured mean medication adherence during the intervention and 2) six months post intervention, along with 3) timeliness of medication adherence during the intervention and 4) six months post-intervention.

A commonly used manualized outpatient methamphetamine intervention for gay and bisexual men, "Getting Off," is being translated into a mobile phone application (i.e., app) available for download through common app marketplaces. The application will provide games, guided lessons, informational support, and resources to gay and bisexual men seeking to reduce their methamphetamine use and risky sexual behaviors.

Despite the need for consistent adherence to medical care, youth living with HIV have low rates of adherence to medications and treatment. There are few interventions to improve adherence to HIV medications and treatment for youth, and there is a great need for novel approaches that are engaging for this age group. The investigators developed an intervention that includes a mobile gaming app that is integrated with a 7-day electronic medication device and text messages. During gameplay, youth fight HIV in colorful organ systems. A small previous project found that the intervention helped youth who were newly starting medications for HIV by improving adherence and decreasing HIV virus in their bodies (viral load). This proposed project will test the intervention with larger number of youth (100) who are newly starting HIV treatment and medications in New England, Georgia, and in Mississippi. The investigators want to determine if adherence is improved and viral load is reduced in this larger sample.

An acceptance and feasibility study for immediate ART initiation and storage of laboratory specimens for individuals with suspected acute HIV infection who are diagnosed in one of the 7 participating emergency rooms

The administration of combination antiretroviral therapy (cART) to HIV-infected patients has been associated with a dramatic reduction in AIDS-related morbidity and mortality. Time to cART start is currently approximately 2-4 weeks after diagnosis, mostly deferred for reasons of waiting for baseline blood test results; in particular HIV genotype, CD4 count, OI screen and logistics of a consultant clinical review. Whilst there is a clear rationale for this delay there is a risk of loss to follow-up as well as the potential risk of onward viral transmission. The balance between "readiness" to start ART against pragmatic and practical safe initiation of treatment needs to be tested using currently available safe potent antiretroviral agents in a head-to-head comparison study to allow careful rigorous comparisons of outcomes. This study will recruit 36 newly diagnosed HIV patients to be started on treatment immediately upon diagnosis. This would optimally be within 7 days, for eligibility to the study up to 14 days will be permissible. Patients will be randomised to one of two open-label combination therapies known to be highly effective; Biktarvy or Symtuza. The patients will receive study treatment for 48 weeks. The two therapies will be compared by the change in HIV viral load from start of treatment to 12 weeks. Further clinical data will be recorded for the trial patients and exploratory investigations undertaken. As those recruited to the trial may not be representative of the full cohort of newly diagnosed HIV patients there will also be data collected on all newly diagnosed patients in a given period. This data will contribute to conclusions on the benefits and issues of implementing test and treat.

The purpose of this study is to collect quantitative data related to developing and testing a couple-based intervention (CBI) for HIV-positive women's medication adherence in the region of Kwazulu-Natal, South Africa. The CBI, called START (Supporting Treatment for Anti-Retroviral Therapy) Together, will be a manualized intervention focused on women's ART adherence and enhancing the couple's communication and problem-solving behavior. The study focuses on implementation outcomes (feasibility, acceptability, and fidelity) and preliminary efficacy outcomes (women's ART adherence, men's engagement in HIV care, and the couple's relationship functioning), which will be compared to a control condition of referrals to usual HIV care.

This study will implement an intervention in a two-year randomized controlled trial (RCT) to establish efficacy on viral suppression as a biological endpoint, compare the effectiveness of two different modes of implementation (including one entirely based on readily available clinic data), and investigate cost-effectiveness. Participants in the first intervention group (T1, n=110) will be eligible for small lottery prizes based on timely clinic visits, and qualify for an annual lottery conditional if demonstrating viral suppression; those in the second group (T2, n=110) will draw prizes conditional on electronically measured adherence at each clinic visit, and also participate in an annual lottery that is conditional on high adherence throughout the year. The control group (n=110) will receive the usual standard of care. Assessments will be conducted at baseline and then every six months. Primary outcomes are undetectable viral load and electronically measured adherence.

This phase II trial studies surgery in treating patients with anal canal or perianal cancer that is small and has not spread deeply into the tissues and human immunodeficiency virus (HIV) infection. Local surgery may be a safer treatment with fewer side effects than bigger surgery or radiation and chemotherapy.

The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents. The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg (Part B). The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to < 25 kg.

The main purpose of this study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'. There are many effective treatments for HIV available; however, for late presenting patients the investigators do not know which type of treatment performs best. This is the first large study to compare treatments for patients in this situation, and the investigators hope that the results of this study will help doctors decide which treatments to use in the future. The two different types of treatment the investigators are comparing both contain a mixture of drugs that work together to combat HIV: The Boosted Protease Inhibitor combination (PI) which is a combination tablet containing: darunavir, cobicistat, emtricitabine and tenofovir alafenamide. It was approved for use in Europe under the brand name Symtuza®. The Integrase Inhibitor combination (INI). Which is a combination tablet containing: bictegravir, emtricitabine and tenofovir alafenamide. This is a a newer combination which was approved for use in Europe in June 2018 under the brand name of Biktarvy®. The main difference between the two treatments is how each one fights a HIV infection. They both stop a part of the virus from working (i.e. inhibit it), to prevent it from making copies of itself. The PI treatment contains drugs to stop the protease part of the virus, whereas the INI treatment contains drugs to stop the integrase part. In recent studies, it appears that treatments containing integrase inhibitors may be better for late presenting patients. They have been shown to quickly bring down the amount of virus in the body, and the side effects may be more acceptable to late presenters. To compare the two treatments, half of the participants on this study will be given the PI treatment, and the other half will be given the INI treatment.