Active clinical trials for "Acquired Immunodeficiency Syndrome"

A randomized trial to test the feasibility and acceptability of an intervention to improve retention in HIV primary care in HIV-infected Hispanic immigrants compared to a "treatment as usual" condition. We will measure feasibility, acceptability, study retention, and effect sizes of outcomes in order to inform a larger trial. The intervention design is based on qualitative research with HIV-infected Hispanic immigrants and their HIV providers. The intervention will be led by a Spanish-speaking community health worker trained in HIV health promotion.

The purpose of this study is to test the effectiveness and implementation of a brief, integrated behavioral intervention for HIV medication adherence and substance use in the HIV care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors using a task sharing model in local HIV clinics. The behavioral intervention will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as described in study endpoint section below).

This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278. The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA. The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.

This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy. Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.

HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is the most common cause of death in patients with HIV worldwide. Rifamycins (such as rifampicin [RIF]) are an important component of TB therapy because of their unique activity. The problem is that most protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors (NNRTI) used to treat HIV have significant drug-drug interactions with RIF that can lead to reduced concentrations of these agents with risk of treatment failure or resistance. The non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV) does not present the same significant drug interactions with RIF. EFV-based HIV treatment was tested in patients concomitantly treated with RIF-containing TB therapy, demonstrating that their co-administration can be used safely and effectively. However, the side effect profile of EFV overlaps with the RIF-containing TB regimens and makes the management of treatment toxicities very complex. Integrase inhibitors (INI), such as dolutegravir (DTG), may offer an important alternative to EFV-based therapy in TB coinfected patients. A Phase I drug-drug interaction study was conducted in healthy, HIV-seronegative subjects, and showed that DTG at 50 mg twice daily given together with RIF was well-tolerated and resulted in DTG concentrations similar to those of DTG 50 mg given once daily alone, which is the recommended dose for INI-naive patients. Therefore, ART regimens using DTG 50 mg twice daily may represent a new treatment option for TB-infected patients who require concurrent treatment for HIV infection. This is a Phase III b, randomized, open-label study describing the efficacy and safety of DTG and EFV-containing ART regimens in HIV/TB co-infected patients. This study is designed to assess the antiviral activity of DTG or efavirenz (EFV) ART-containing regimens through 48 weeks. A total of approximately 115 +/-5% subjects will be randomly assigned in a 3:2 ratio to DTG (approximately 69 subjects) and EFV (approximately 46 subjects), respectively. This study will include a Screening Period, a Randomized Phase (Day 1 to 48 weeks plus a 4-week extension), and a DTG Open-label extension (OLE). During the DTG OLE, subjects will be supplied with DTG until it is locally approved and commercially available, the subject no longer derives clinical benefit, or the subject meets a protocol-defined reason for discontinuation, which ever comes first.

This study is being done to compare three strategies to deliver HCV treatment with ledipasvir/sofosbuvir which is an approved therapy which is administered as one tablet by mouth daily for 12 weeks. The study population is persons living with HIV and hepatitis C virus (HCV) coinfection who also use drugs. Participants will be randomized into one of three treatment groups: Usual care in the clinic. This treatment group will receive the standard of care for HCV treatment from their health care team. Usual care plus peer-mentors. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection. Usual care plus incentives. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain treatment goals during the course of the study. HCV treatment with ledipasvir/sofosbuvir is considered the standard of care for HCV and is recommended by experts in liver disease and infectious diseases.

The purpose of this study is to compare the antiretroviral activity of doravirine, tenofovir, lamivudine (MK-1439A), a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing doravirine (MK-1439) 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg, in treatment-naive participants infected with human immunodeficiency virus (HIV). The primary hypothesis is that doravirine, tenofovir, lamivudine q.d. is non-inferior to ATRIPLA™ q.d. as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL (by the Abbott RealTime HIV-1 Assay) at Week 48. This study has a total duration of 192 weeks, including a 96-week double-blind period and a 96-week open-label period. The present results are based on the first 48 weeks of this ongoing study.

Treatment of human immunodeficiency virus (HIV) infection requires daily oral administration of a combination of antiretroviral drugs to reduce the patient's HIV levels. Dolutegravir (DTG), a HIV-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are approved for the treatment of HIV infection. This study is aimed to evaluate the relative bioavailability and food effect of single doses of several experimental fixed dose combination (FDC) tablets of Dolutegravir 50 milligrams (mg) and Rilpivirine 25 mg (DTG/RPV 50 mg/25 mg) relative to co-administration of a single dose of the reference single entity products (DTG 50 mg and RPV 25 mg) in healthy adult subjects. This is a 2-part study. Part 1 will be conducted as a randomized, open label, 3-way, crossover design in 24 subjects. Part 1 will evaluate the relative bioavailability of up to 4 test formulations relative to the reference single entity products administered in fed state. Part 2 will be conducted as a randomized, open-label, 3-way crossover design in 3 distinct cohorts each with 12 subjects. Part 2 will evaluate the relative bioavailability of up to 3 most promising FDC formulation selected from Part 1 (DTG/RPV FDC-1, DTG/RPV FDC-2, DTG/RPV FDC-3) administered in fasted and fed state. Subjects will also receive the reference treatment from Part 1 co-administered under fasted conditions. This study will consist of a screening visit, three treatment periods each with a single dose of study drug separated by a washout of at least 9 days and a follow-up visit. The total duration of participation of a subject in this study will be approximately 10 weeks.

ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is intended to assess the safety, the tolerability, and pharmacokinetic parameters and to evaluate the effect on viral load of repeated oral administrations of ABX464 in patients infected by HIV, not previously treated for their HIV. Two types of design are intended in this protocol: dosing every 3 days or dosing every day. The goal is to determine the best dosing regimen to reduce viral load and minimize adverse events.

The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to standard treatment) in terms of the percentage of patients who have plasma human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per mL after 48 weeks of randomized treatment with tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).