HIV Infections
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CLINICAL_TRIALS trial_result · 2025-02-18Clinical Trial Update: A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants [Phase 1]
Phase 1 study to evaluate the effect of food on the bioavailability of a Capsid Inhibitor (CAI) in healthy male and female participants; the…
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CLINICAL_TRIALS trial_result · 2025-02-10Clinical Trial Update: A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants [Phase 1]
Phase 1 safety, tolerability, and pharmacokinetics study of PGDM1400LS alone and in combination with VRC07-523LS and PGT121.414.LS in health…
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CLINICAL_TRIALS trial_result · 2025-02-06Clinical Trial Update: Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana
A completed clinical trial evaluating the pharmacokinetics of antiretroviral drugs in lactating women and their breastfed infants under 6 mo…
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CLINICAL_TRIALS trial_result · 2025-01-30Clinical Trial Update: Aging With HIV and Neurocognitive Decline, a Follow-up Study [NA]
This clinical trial update indicates the follow-up study on aging with HIV and neurocognitive decline (NCT05385588) has completed, sponsored…
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CLINICAL_TRIALS research · 2025-01-30Clinical Trial Update: Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms [NA]
Clinical trial update on negative serology by immunoenzymatic assay in HIV-infected children treated early with antiretroviral therapy withi…
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CLINICAL_TRIALS trial_result · 2025-01-29Clinical Trial Update: Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males [Phase 2]
Results from a Phase 2 trial evaluating the safety, tolerability and acceptability of long-acting cabotegravir for HIV prevention in adolesc…
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CLINICAL_TRIALS research · 2024-10-08Clinical Trial Update: The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir [Phase 3]
Phase 3 study evaluating injectable cabotegravir for HIV pre-exposure prophylaxis is currently recruiting.
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CLINICAL_TRIALS trial_result · 2024-09-27Clinical Trial Update: Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment [NA]
A University of Pennsylvania-led clinical trial evaluating HealthMPowerment to increase engagement and improve HIV outcomes has completed, w…
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CLINICAL_TRIALS trial_result · 2024-09-03Clinical Trial Update: Young Men's Health Project Targeting HIV Risk Reduction and Substance Abuse [NA]
Completion and results posting of a clinical trial by Florida State University aiming to reduce HIV risk and substance abuse among young men…
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CLINICAL_TRIALS trial_result · 2024-07-05Clinical Trial Update: Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants [Phase 1]
Phase 1 study evaluating safety, tolerability, and pharmacokinetics of monoclonal antibodies in healthy participants for HIV research; the t…
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CLINICAL_TRIALS trial_result · 2024-04-22Clinical Trial Update: Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants [Phase 1]
A Phase 1 pharmacokinetic study of long-acting cabotegravir and rilpivirine injections in healthy adults has completed, with results posted.
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CLINICAL_TRIALS trial_result · 2024-04-19Clinical Trial Update: The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study [Phase 4]
A Phase 4 clinical trial update for the ASAP-Switch study evaluating antiretroviral switching strategies in people with HIV.
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CLINICAL_TRIALS trial_result · 2024-04-18Clinical Trial Update: Virtual PrEP: Rendering PrEP Delivery More Efficient [Phase 4]
Phase 4 clinical trial update for Virtual PrEP evaluating more efficient delivery; study terminated.
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CLINICAL_TRIALS trial_result · 2024-04-17Clinical Trial Update: Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT [Phase 3]
Phase 3 randomized trial investigating long-acting HIV pre-exposure prophylaxis integrated with sexual and reproductive health services.
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CLINICAL_TRIALS trial_result · 2024-03-18Clinical Trial Update: Get Connected Efficacy Trial [NA]
Clinical trial results for an HIV infection study sponsored by the University of Pennsylvania have been completed with results posted in Mar…
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EMA approval · 2024-02-23EMA Authorised: Fuzeon (enfuvirtide) — Roche Registration GmbH
A European Medicines Agency page indicates that Fuzeon (enfuvirtide) by Roche Registration GmbH is authorised for HIV infections.
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CLINICAL_TRIALS trial_result · 2024-02-09Clinical Trial Update: Combination Latency Reversal With High Dose Disulfiram Plus Vorinostat in HIV-infected Individuals on ART [Phase 1, Phase 2]
A phase 1/2 trial evaluating high-dose disulfiram plus vorinostat as a latency reversal strategy in HIV-infected individuals on ART has been…
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CLINICAL_TRIALS trial_result · 2023-12-22Clinical Trial Update: Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally [Phase 1]
Phase 1 safety and pharmacokinetic study of rectally administered Tenofovir Alafenamide/Elvitegravir in HIV infections completed with result…
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CLINICAL_TRIALS trial_result · 2023-12-21Clinical Trial Update: Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE) [NA]
A completed clinical trial update from CARE2HOPE initiative addressing substance use and HIV-related conditions, with results posted in 2023…
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CLINICAL_TRIALS trial_result · 2023-12-14Clinical Trial Update: A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults [Phase 2]
Phase 2 trial of GSK3640254 plus dolutegravir in treatment-naive HIV-1 adults was terminated.
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CLINICAL_TRIALS trial_result · 2023-12-06Clinical Trial Update: Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction Compared to Placebo and a Single Oral Dose of Moxifloxacin [Phase 1]
Phase 1 trial evaluating effects of GSK3640254 at therapeutic and supratherapeutic doses on cardiac conduction compared to placebo and moxif…
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CLINICAL_TRIALS trial_result · 2023-12-01Clinical Trial Update: 3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study [Phase 2]
Phase 2 trial evaluating three tipranavir/ritonavir dose regimens in antiretroviral-experienced people with HIV infection.
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CLINICAL_TRIALS trial_result · 2023-12-01Clinical Trial Update: Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients [Phase 2]
Phase 2 trial update evaluating pharmacokinetics of tipped boosted protease inhibitor therapy (tipranavir/ritonavir) in highly treatment-exp…
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CLINICAL_TRIALS trial_result · 2023-10-04Clinical Trial Update: DTG Plus 3TC for Prophylaxis of Mother-to-child Transmission of HIV Infection in Pregnant Women [Phase 3]
Phase 3 trial update on DTG plus 3TC as prophylaxis for preventing mother-to-child transmission of HIV during pregnancy; study completed.
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EMA withdrawal · 2023-09-25EMA Withdrawn: Invirase (saquinavir) — Roche Registration GmbH
The EMA withdrew Invirase (saquinavir) from registration in the EU, with Roche Registration GmbH as the MAH, in March 2023.