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HIV-1 Infection clinical trials

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NCT ID: NCT05096949 Terminated - Clinical trials for Medication Adherence

Implementing Cabenuva in Arkansas HIV Programs

Start date: March 7, 2022
Phase: N/A
Study type: Interventional

This study seeks to address this gap by studying two Cabenuva delivery strategies conducted at six outpatient HIV clinics in Arkansas, a Southern state with a large population of rural, poor, and African-American residents. The two delivery strategies are clinic delivery and home delivery. In the clinic delivery study arm patients will receive Cabenuva injections at the clinic (50 patients), and in the home delivery study arm patients will receive the injections at home (50 patients). The study team will follow the patients in both study arms for 10 months. After 5 months, the patients will complete a treatment satisfaction survey, and after 10 months the study team will examine clinic records to assess their medication adherence. Secondary outcomes will include clinician perceptions of acceptability, feasibility, and appropriateness of Cabenuva delivery strategies. The study team will also collect qualitative data from patients and clinic employees to learn more in depth about their perceptions of Cabenuva, the delivery strategies, their implementation, and barriers and facilitators. Finally, the study team will estimate the costs associated with the two delivery strategies from the clinic and patient perspectives. The data from this study provide information on what delivery strategies for long acting HIV medications offer best results, how these strategies are perceived by patients and clinicians, and how costly and feasible the strategies are to implement in practice.

NCT ID: NCT04201782 Terminated - HIV-1-infection Clinical Trials

Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T

Start date: March 18, 2011
Phase:
Study type: Observational

Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T. Enrolling subjects will be followed for a total of 12 years.

NCT ID: NCT04138199 Terminated - HIV-1 Infection Clinical Trials

A Study to Assess Effectiveness and Safety of Fixed Dose Combination of Lopinavir/Ritonavir (LPV/r) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients After Switching From Kaletra in the Routine Clinical Settings of Russian Federation

COPI
Start date: November 1, 2019
Phase:
Study type: Observational

This is a mixed prospective-retrospective, multi-center observational study to assess the virologic effectiveness of generic product of Lopinavir/Ritonavir (LPV/r) after switching from Kaletra in the routine clinical settings of Russian Federation.

NCT ID: NCT04040075 Terminated - HIV-1-infection Clinical Trials

Testing the Safety and Efficacy of Commercial Drug Biktarvy in Subjects Known to Have the 184 Resistance Mutation to a Component in Biktarvy

Start date: July 1, 2019
Phase: Phase 4
Study type: Interventional

An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation

NCT ID: NCT03705169 Terminated - HIV-1-infection Clinical Trials

Pharmacokinetics and Safety of SAR441236

Start date: May 20, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of SAR441236, a tri-specific broadly neutralizing antibody against the human immunodeficiency virus (HIV).

NCT ID: NCT03532425 Terminated - HIV-1-infection Clinical Trials

B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults

Start date: October 29, 2018
Phase: Phase 4
Study type: Interventional

Atripla (ATP: FTC/TDF/EFV) was the first single pill treatment for HIV and was the most prescribed first-line treatment from approximately 2008 to 2013 for people infected with HIV. However, ATP has not been recommended as a "preferred" treatment for HIV since 2015, due to there now being single pill treatments that work better. There are a lot of people who are still taking ATP and it is working for them. However, it has the potential to cause serious side effects (chronic kidney disease and fractures and serious neurological effects). These side effects are caused by components in ATP (namely the TDF and EFV parts). Also, the efavirenz (EFV) component is not compatible for treatment of Hepatitis C (HCV) - which is often also seen in people who have HIV. For these reasons, there is a need to find a better alternative treatment for these people currently being treated with ATP.

NCT ID: NCT03493568 Terminated - HIV-1-infection Clinical Trials

Switch From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to E/C/F/TAF in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE)

Be-OnE
Start date: February 6, 2017
Phase: Phase 3
Study type: Interventional

Research hypothesis: Switching from dual regimens based on dolutegravir plus a RTI to a single tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), lowers the exposure to Residual Viremia (and hence the risk of viral rebound), without increasing treatment toxicity.

NCT ID: NCT03472326 Terminated - HIV-1-infection Clinical Trials

Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus

Start date: April 3, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the short-term antiviral potency of GS-9131 functional monotherapy compared to placebo-to-match (PTM) GS-9131, each administered once daily with the existing failing antiretroviral (ARV) regimen as demonstrated by the proportion of participants achieving human immunodeficiency virus ribonucleic acid (HIV-1 RNA) > 0.5 log10 decreases from baseline after up to 14 days of therapy in HIV-1 positive, ARV treatment experienced adult participants with nucleos(t)ide resistant virus. This is a two-part study. Part 1 consists of three cohorts: 2 Sentinel Cohorts and 1 Randomized Cohort. Eligible participants from Part 1 will proceed to Part 2 followed by an optional open-label extension.

NCT ID: NCT03101592 Terminated - HIV-1-infection Clinical Trials

INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV

INTERVAL
Start date: May 31, 2017
Phase: N/A
Study type: Interventional

This is an unblinded cluster-randomized study to evaluate the effectiveness of two strategies for scripting/dispensing of antiretroviral therapy (ART) on retention, virologic suppression, and cost compared to the standard of care. The study will be conducted in Malawi and Zambia among approximately 8,200 HIV-1-infected adults (18 years or older) who are stable on ART. Clusters will be randomized to one of three study arms: (1) standard of care (SOC) ART scripting (varies by country, region, clinic, and/or provider), (2) three-month ART scripting, and (3) six-month ART scripting. 30 clusters will be selected for the study, 15 in Malawi and 15 in Zambia, and will be randomized to a study arm.

NCT ID: NCT02972450 Terminated - HIV-1-infection Clinical Trials

An HIV Vaccine Trial in Individuals Who Started ART During Primary or Chronic Infection

EHVAT01
Start date: February 20, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

EVHA T01 is an international, phase I/II, multicentre, multi-stage, double-blind study that will evaluate at least three experimental arms compared to placebo control in HIV-1 infected participants to see if one or more has a clinically relevant impact on the control of viral replication.