|
Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women Clinical research trials and Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women. Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women clinical trial. Participants frequently get the best healthcare available for their Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women  Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women
Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women
For Condition: HIV Infection
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will determine if blood levels of anti-HIV drugs in pregnant women change at different stages of pregnancy and if these changes require dosage adjustments in order to maintain adequate drug levels during pregnancy. Anti-HIV medications are recommended for HIV-infected women during pregnancy not only to treat their infection, but also to reduce the chance of passing the virus to the baby during pregnancy. Changes in the body that occur during pregnancy may affect how the body uses and eliminates these drugs, reducing their levels during pregnancy. Pregnant women 18 years of age or older who are infected with HIV may be eligible for this study. Candidates will have a medical history and physical examination, pregnancy test and blood tests. Participants will come to the NIH Clinical Center once every 6 to 12 weeks until around their 34th week (8 months) of pregnancy and then again at least 1 month after the birth of the baby to have blood drawn. A catheter (thin plastic tube) will be placed in a vein to avoid multiple needle sticks for blood sampling during the day. The first sample will be collected before the patient takes the morning doses of anti-HIV medicines and additional samples will be drawn at 1, 2, 4, 8 and 12 hours after taking the medication. A urine sample will also be collected at each visit.
Details: Highly active antiretroviral therapy is currently recommended for HIV-1 infected pregnant women for the management of maternal HIV infection and for prevention of perinatal HIV transmission. Many physiological changes occur during pregnancy may lead to changes in pharmacokinetics of drugs. Some of these pharmacokinetic changes may include increases in volume of distribution and total body clearance as well as decreases in oral absorption, area under the concentration time curve, peak and trough concentrations. All of these changes may result in decrease in drug exposure. Other than zidovudine, little is known about the pharmacokinetics of other antiretroviral agents during pregnancy. A number of studies have suggested a correlation between trough concentration: IC50 ratio and virological responses. The objective of the study is to examine the pharmacokinetics of antiretroviral agents during different stages of pregnancy in comparison with the non-pregnant state (post-partum and historical control). HIV infected pregnant women in general good health who are on at least three antiretroviral drug combination will be enrolled in the study. Pharmacokinetic profiles of the antiretroviral agents taken by the subjects will be obtained two to four times during pregnancy and again at around one month post-partum. These data will be used to assess the need for dosage adjustment or therapeutic drug monitoring of antiretroviral agents during pregnancy.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA: HIV-1 positive as documented by ELISA and confirmed by Western Blot test Positive urine pregnancy test or positive serum Beta-HCG Age greater than or equal to 18 years At least 14-week gestation at the time of screening as estimated by the subject's obstetrician Having a normal pregnancy per the subject's obstetrician's assessment Maintained on or to be started on a HAART regimen containing at least three antiretroviral agents Hgb greater than or equal to 10 gm/dL, platelet greater than or equal to 100,000/mL, PT less than or equal to 14.0 sec S.Cr. less than 2.0 mg/dL, ALT and AST less than or equal to 2 times the upper limit of normal EXCLUSION CRITERIA: Receiving treatment for an active HIV-related opportunistic infection Significant medical conditions such as diabetes (including gestational diabetes), hypertension, coronary artery disease, seizure disorder, asthma, or other medical conditions that in the investigators' opinion will not be safe for the subject to participate in this study History of significant obstetric complications during prior pregnancy(ies) Concurrent illicit drug or alcohol abuse Not receiving ongoing medical care for HIV infection and pregnancy Efavirenz as part of HAART regimen Combination of didanosine and stavudine as part of HAART regimen Presence of persistent diarrhea or history of malabsorption that will interfere with the subject's ability to absorb the antiretroviral drugs Refusal to allow the investigators to obtain medical records from her HIV care provider and her obstetricians during the course of the study Unable to obtain venous access for blood draw Refusal to agree to allow the specimen to be stored for future research
Total Enrollment: 20
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 000213; 00-I-0213
Study Start Date: September 22, 2000
Record last reviewed: October 3, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006320
Other Hiv Infection Studies:
1. Phase I Study to Evaluate the Safety and Immunogenicity of HIV-1 Immunogen in Children with HIV-1 Infection
2. Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women
3. Screening HIV-Infected Patients for Vaccine Studies
4. Intermittent vs. Continuous HAART to Treat Chronic HIV Infection
5. Evaluation of the Significance of Anti-HIV Antibody in Asymptomatic Blood Donors
Related Studies:
Other HIV Infection Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women
|
|
|
|
|
|
|
|
