The Benefits of Immediate Treatment Initiation Without Immunovirological Data Compared to Conventional...
HIV-1-infectionPhase IV, single-center, open study to assess the benefits of the start of immediate treatment without immunovirological data ("Same Day Treatment") compared to conventional treatment with BIC / FTC / TAF in naive patients with type 1 HIV (human immunodeficiency virus) infection
Rudi Kundini, Pamoja Kundini
HIV (Human Immunodeficiency Virus)This protocol describes an individually randomized trial that will include adult people living with HIV (PLHIV) currently receiving HIV care at one of two participating health facilities and identified as high risk for disengagement from care by a machine learning algorithm. Participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the management of HIV. For those who meet clinic eligibility criteria for enhanced adherence counseling, which at the included study sites is when client's viral load reaches a detectable level (>1000 copies/ml), this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Intervention arm participants will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (referred to as PKC sessions).
HIV A6 Genome In ART Unsuccessful Patients On DOR
Virus-HIVThe aim of the study is to evaluate the efficacy of Doravirine (DOR) in the second-line therapy for patients infected with HIV-1 sub-subtype A6 and its derivatives and having the mutations to previously used drugs
Doravirine, Rifapentine and Isoniazid Interaction
Latent TuberculosisHuman Immunodeficiency Virus2 moreDrug therapy for persons living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is complex. Anti-tuberculosis drugs used to treat LTBI often induce drug metabolizing enzymes that share the same metabolic pathway as antiretroviral drugs used for those living with HIV/AIDS. This study evaluates the drug-drug interaction (DDI) potential of an antiretroviral drug when co-administered with a common anti-tuberculosis regimen of drugs.
A Study of MK-8527 in Human Immunodeficiency Type 1 Virus (HIV-1) Infected Participants (MK-8527-002)...
Human Immunodeficiency VirusAIDS VirusThis study will evaluate the anti-retroviral activity of MK-8527 in HIV-1 infected, ART-naïve participants. The primary hypothesis is that MK-8527 has superior anti-retroviral activity compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.
Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants...
Human Immunodeficiency Virus (HIV) InfectionThis study is designed to evaluate safety, tolerability, and pharmacokinetics of a single 1200-mg dose of raltegravir (MK-0518, ISENTRESS®) in healthy Japanese male participants.
Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment...
HIVHIV Infections1 moreThe primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen. There are 2 parts to this study: Part 1 and Part 2. Part 1 consists of 2 cohorts, starting with a sentinel cohort, in which participants will be enrolled to receive open-label TAF in addition to their current failing ARV regimen. This cohort will then be followed by a randomized, double-blind, cohort to compare the addition of TAF or placebo in HIV-1 positive adults who are failing their current ARV regimen. In Part 2, all participants who complete Part 1 of the study will discontinue their failing ARV regimen and TAF or placebo for a 14-day washout period. Following the washout period, all participants who received TAF in Part 1 and have a > 0.5 log10 decline in HIV-1 RNA will receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) plus atazanavir (ATV) once daily for 48 weeks. Participants who received TAF who have a ≤ 0.5 log10 decline in HIV-1 RNA will be discontinued from the study and will not be eligible to continue into Part 2 of the study. All participants who received placebo in Part 1 will be eligible to participate in Part 2 regardless of their viral load change. After completion of Part 2, all participants will be eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF becomes commercially available, or until Gilead Sciences terminates development of E/C/F/TAF in the applicable country.
A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor...
InfectionHuman Immunodeficiency VirusThe purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.
Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild...
Acquired Immunodeficiency SyndromeHIV InfectionsThis study is to characterize the effect of cobicistat-based regimens on parameters of renal function in participants with HIV infection and who have mild to moderate renal impairment, and to assess the safety and tolerability of the regimens in order to generate appropriate dosing recommendations.
Atorvastatin for HAART Suboptimal Responders
Acquired Immune Deficiency Syndrome VirusWe hypothesise that atorvastatin changes immune activation among HAART-treated adults with suboptimal cluster cell differentiation 4 (CD4) recovery by 25%