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63 results for “cabotegravir”
More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents
ClinicalTrials.gov study NCT03497676. IPD Sharing: YES. Countries: 5. Publications: 6.
Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1
ClinicalTrials.gov study NCT03739996. IPD Sharing: YES. Countries: 2. Publications: 1.
Compendial testing data of bictegravir and cabotegravir
<p>ISO/IEC 17043:2015, specifies general requirements for the competence of providers and development and operation of proficiency testing schemes. As a requirement of ISO/IEC 17043:2015 accreditation, the Clinical Pharmacology Quality Assurance Program uses ISO 17034 certified reference materials (CRMs) to produce proficiency testing materials. When CRMs that meet the ISO/IEC 17034 standard are not available or are prohibitively expensive, the purity and identity of non-certified standards must be authenticated by compendial testing to establish fit for intended use. Here, we report on a compendial testing approach used to assess whether standard reference materials for bictegravir and cabotegravir, two emerging drugs used in the treatment of HIV infection, are suitable for proficiency testing. Our approach uses high performance liquid chromatography and thermogravimetric analysis to evaluate purity of the materials and high-resolution mass spectrometry and proton nuclear magnetic resonance spectroscopy to establish molecular identity. Using this approach, we were able to certify standard reference materials for bictegravir and cabotegravir that are suitable for proficiency testing, providing some lower-costs alternatives.</p>
Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US)
ClinicalTrials.gov study NCT04001803. IPD Sharing: YES. Countries: 1. Publications: 2.
Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human
ClinicalTrials.gov study NCT03639311. IPD Sharing: YES. Countries: 2. Publications: 2.
Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine
ClinicalTrials.gov study NCT06185452. IPD Sharing: YES. Countries: 1. Publications: 1.
A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries
ClinicalTrials.gov study NCT04399551. IPD Sharing: YES. Countries: 5. Publications: 2.
Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
ClinicalTrials.gov study NCT02720094. IPD Sharing: Not stated. Countries: 7. Publications: 7.
Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants
ClinicalTrials.gov study NCT04484337. IPD Sharing: YES. Countries: 2. Publications: 0.
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females
ClinicalTrials.gov study NCT04824131. IPD Sharing: Not stated. Countries: 3. Publications: 1.
A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
ClinicalTrials.gov study NCT05374525. IPD Sharing: YES. Countries: 1. Publications: 0.
A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
ClinicalTrials.gov study NCT03422172. IPD Sharing: YES. Countries: 1. Publications: 1.
Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
ClinicalTrials.gov study NCT03164564. IPD Sharing: Not stated. Countries: 7. Publications: 3.
Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects
ClinicalTrials.gov study NCT03149848. IPD Sharing: YES. Countries: 1. Publications: 1.
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infe
ClinicalTrials.gov study NCT02951052. IPD Sharing: YES. Countries: 13. Publications: 7.
Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor
ClinicalTrials.gov study NCT02938520. IPD Sharing: YES. Countries: 11. Publications: 12.
A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Vi
ClinicalTrials.gov study NCT04542070. IPD Sharing: YES. Countries: 14. Publications: 5.
Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults
ClinicalTrials.gov study NCT03299049. IPD Sharing: YES. Countries: 13. Publications: 8.
Compendial testing data of bictegravir and cabotegravir
Open the record for dataset details and reuse information.
PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offere
ClinicalTrials.gov study NCT06807736. IPD Sharing: UNDECIDED. Countries: 1. Publications: 1.
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