HIV Infection
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2023-12-20Clinical Trial Update: Strategic Timing of Antiretroviral Treatment [Phase 4]
A Phase 4 clinical trial evaluating the strategic timing of antiretroviral therapy in HIV infection has completed with results posted.
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CLINICAL_TRIALS withdrawal · 2023-12-19Clinical Trial Update: Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone [Phase 3]
Phase 3 trial evaluating ritonavir-boosted atazanavir or darunavir with optimized NRTI backbone for second-line HIV-1 treatment has been wit…
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CLINICAL_TRIALS research · 2023-12-18Clinical Trial Update: Pharmacokinetics and Safety of DolutegravIr in Neonate [Phase 1, Phase 2]
A phased pharmacokinetics and safety trial of dolutegravir in neonates investigating early-life drug exposure and tolerability.
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FDA approval · 2023-12-13FDA Approved: VOCABRIA — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for VOCABRIA (cabotegravir sodium) from ViiV Healthcare Company, representing an additional regulato…
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FDA approval · 2023-12-13FDA Approved: CABENUVA — Supplemental Application (ViiV Healthcare Company)
FDA supplemental application for CABENUVA (cabotegravir and rilpivirine) submitted by ViiV Healthcare Company under NDA 212888; this entry d…
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FDA approval · 2023-12-13FDA Approved: APRETUDE — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for APRETUDE (cabotegravir) filed by ViiV Healthcare Company, resulting in an updated labeling/indic…
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FDA approval · 2023-12-13FDA Approved: DARUNAVIR — Original Application (Zydus Lifesciences Limited)
FDA approved the Original Application for generic darunavir (DARUNAVIR) by Zydus Lifesciences Limited for the treatment of HIV-1 infection i…
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FDA label_change · 2023-12-12FDA Approved: TROGARZO — Supplemental Application (Theratechnologies Inc.)
FDA approved a supplemental application for TROGARZO (ibalizumab) filed by Theratechnologies, resulting in changes to the product labeling.
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CLINICAL_TRIALS trial_result · 2023-12-12Clinical Trial Update: The Influence of Concurrent Oral Calcium Carbonate Supplementation on Steady State Pharmacokinetics of Oral Raltegravir. [Phase 4]
Phase 4 trial update evaluating whether concurrent oral calcium carbonate affects steady-state pharmacokinetics of oral raltegravir in HIV p…
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CLINICAL_TRIALS trial_result · 2023-12-11Clinical Trial Update: Islatravir and Methadone Pharmacokinetics (MK-8591-029) [Phase 1]
Phase 1 pharmacokinetic study evaluating islatravir (MK-8591) in individuals taking methadone; results posted.
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CLINICAL_TRIALS trial_result · 2023-12-08Clinical Trial Update: Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019) [Phase 3]
Phase 3 trial MK-8591A-019 evaluating the Doravirine/Islatravir combination in heavily treatment-experienced HIV-1 infection reported result…
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FDA approval · 2023-12-08FDA Tentative Approval: DARUNAVIR — Original Application (Amneal Pharmaceuticals NY LLC)
FDA issued tentative approval for Amneal Pharmaceuticals NY LLC's generic darunavir (DARUNAVIR) under an ANDA, permitting marketing for HIV-…
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CLINICAL_TRIALS trial_result · 2023-12-08Clinical Trial Update: Postpartum Pre-exposure Prophylaxis (PrEP) Study to Evaluate an Adherence Promotion Package for Postpartum Women on PrEP [NA]
A completed clinical trial evaluating an adherence promotion package for postpartum women on PrEP (pre-exposure prophylaxis) for HIV infecti…
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CLINICAL_TRIALS trial_result · 2023-12-08Clinical Trial Update: Evaluation of Secondary Distribution of HIV Self-screening Tests by Women With HIV [NA]
A completed clinical trial evaluating secondary distribution of HIV self-screening tests by women with HIV; results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-12-01Clinical Trial Update: A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions [Phase 4]
A Phase 4 pharmacokinetic study evaluating nevirapine levels in HIV-infected patients with hepatic impairment.
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CLINICAL_TRIALS trial_result · 2023-11-29Clinical Trial Update: Dual Therapy With Boosted Darunavir + Dolutegravir [Phase 3]
Phase 3 clinical trial update on boosted darunavir plus dolutegravir for HIV infection has completed.
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FDA approval · 2023-11-28FDA Approved: DARUNAVIR 600 AND 800 MG — Original Application (Cipla USA Inc.)
FDA approves Cipla USA's generic darunavir tablets in 600 mg and 800 mg strengths under an Original Application for HIV-1 infection.
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FDA approval · 2023-11-28FDA Approved: DARUNAVIR — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for generic darunavir from Aurobindo Pharma Limited.
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FDA approval · 2023-11-28FDA Approved: DARUNAVIR — Original Application (Novadoz Pharmaceuticals LLC)
FDA approved the original application for a generic darunavir product by Novadoz Pharmaceuticals LLC for HIV-1 infection.
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FDA approval · 2023-11-28FDA Approved: DARUNAVIR — Original Application (Dr.Reddys Laboratories Inc)
FDA approved Dr. Reddy's Laboratories' original application for Darunavir, an HIV protease inhibitor used in antiretroviral therapy for HIV …
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CLINICAL_TRIALS trial_result · 2023-11-24Clinical Trial Update: Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men [Phase 2, Phase 3]
Phase 2/3 clinical trial comparing injectable cabotegravir to TDF/FTC for HIV pre-exposure prophylaxis in HIV-uninfected men and transgender…
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CLINICAL_TRIALS trial_result · 2023-11-21Clinical Trial Update: Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020) [Phase 3]
Phase 3 study MK-8591A-020 assessing Doravirine/Islatravir for treatment-naïve HIV-1 infection completed with results posted.
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CLINICAL_TRIALS trial_result · 2023-11-21Clinical Trial Update: Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020) [Phase 3]
Phase 3 trial evaluating doravirine/islatravir combination in treatment-naïve HIV-1 patients; study completed with results posted.
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CLINICAL_TRIALS trial_result · 2023-11-21Clinical Trial Update: Exercise Training to Improve Brain Health in Older HIV+ Individuals [NA]
A terminated clinical trial investigated exercise training as a strategy to improve brain health in older individuals living with HIV; resul…
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FDA approval · 2023-11-19FDA Approved: DARUNAVIR — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approves Lupin Pharmaceuticals' supplemental application for Darunavir, enabling the sale of a generic darunavir product.