Clinical Trials Logo
  1. Home
  2. HIV Infections
  3. NCT00689910

Pharmacokinetics of Raltegravir During Third Trimester Pregnancy and Post-Partum

HIV Infections Clinical Trial

Official title:
Pharmacokinetics of Raltegravir During Third Trimester Pregnancy and Post-Partum

Clinical Trial Summary

This study will evaluate the pharmacokinetic disposition of raltegravir in pregnant HIV-1 infected women. These results will be compared to pharmacokinetic data obtained following pregnancy as well as to studies previously carried out in nonpregnant women and male patients. By determining the disposition characteristics for this specific patient population, antiretroviral (ARV) dosing can be optimized during pregnancy. Appropriate dosing is necessary to minimize adverse effects, slow progression of disease, and further reduce the risk for vertical transmission. Data will also be obtained on genital tract penetration and placenta transfer of raltegravir to the newborn.

The subjects enrolled in this study will take an antiretroviral based regimen containing raltegravir twice daily both during and after their pregnancy. The specific regimen will be chosen by their own primary care provider based on their antiretroviral history and resistance testing. They will undergo a series of blood sampling for pharmacokinetic analysis over 12 hours on two occasions; a) during their 3rd trimester and b) approximately 3 months postpartum. Concentrations of raltegravir in the infant will be assessed by cord and infant blood sample at delivery and a blood sample at approximately 3 months of age.

Hypothesis: The pharmacokinetic exposure of raltegravir as measured by the 12 hour area under the plasma concentration versus time curve (AUC0-12h) during third trimester pregnancy is similar to the AUC0-12h estimated three months post-partum.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00689910
Study type Observational
Source University of California, San Francisco
Contact
Status Withdrawn
Phase N/A
Start date February 2008
View Details
See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2