Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women

2014-08-27 03:57:24 | BioPortfolio


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.


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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment


HIV Infection


determine blood levels of anti-HIV drugs


National Institute of Allergy and Infectious Diseases (NIAID)
United States




National Institutes of Health Clinical Center (CC)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:57:24-0400

Clinical Trials [3395 Associated Clinical Trials listed on BioPortfolio]

Effectiveness of Anti-HIV Drugs in Patients Who Have Not Received Previous Anti-HIV Drugs During Different Stages of HIV Infection

The purpose of this study is to compare changes in HIV levels and certain immune cells among patients at different stages of HIV infection. This study will also see how a combination of st...

Immune Activity Against CVM Retinitis

This study will investigate whether medication for cytomegalovirus (CMV) retinitis-a viral infection of the eye-can safely be stopped in HIV-infected patients whose immune function has imp...

Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected With HIV

The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV drugs affects the course of HIV disease in patients with primary HIV infection (the time period t...

A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment

The purpose of this study is to see if adding 1 or 2 drugs to the anti-HIV therapy of patients whose HIV levels increased while taking their anti-HIV drugs can lower viral load (amount of ...

A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection

This study evaluates patients infected with both HIV and Hepatitis C virus (HCV) who are receiving anti-HIV drugs. The purpose of this study is to learn more about HCV infection in patien...

PubMed Articles [33460 Associated PubMed Articles listed on BioPortfolio]

Establishment of an animal model of infection and study on therapeutic methods Ⅰ Establishment of an animal model of infection in mice and changes of serum specific antibody levels post-infection.

To establish an animal model of (plerocercoid larva of ) infection in mice and observe the changes of blood routine examinations and serum anti-sparganum antibody levels after the infection.

Anti-band 3 and anti-spectrin antibodies are increased in Plasmodium vivax infection and are associated with anemia.

Clearance of non-infected red blood cells (nRBCs) is one of the main components of anemia associated with Plasmodium vivax malaria. Recently, we have shown that anemic patients with P. vivax infection...

Postoperative Blood Glucose Levels Predict Infection After Total Joint Arthroplasty.

Perioperative hyperglycemia has many etiologies, including medication, impaired glucose tolerance, uncontrolled diabetes mellitus, or stress, the latter of which is common in patients postoperatively....

Development of an in-house ELISA to detect anti-HPV16-L1 antibodies in serum and dried blood spots.

Measuring anti-HPV antibody levels is important for surveillance of the immunological response to both natural infection and vaccination. Here, an ELISA test for measurement of HPV-16L1 antibodies was...

Occult Hepatitis B Infection Among Blood Donors in Al Azhar University Hospital, Upper Egypt: The Current Status After 25 years of Vaccine Introduction.

Occult hepatitis B virus infection (OBI) is a challenging topic with much debate regarding its clinical and virological relevance. The reliance on anti HBc seropositivity for diagnosis of OBI is still...

Medical and Biotech [MESH] Definitions

Test to determine the presence of blood infection (e.g. SEPSIS; BACTEREMIA).

The taking of a blood sample to determine its character as a whole, to identify levels of its component cells, chemicals, gases, or other constituents, to perform pathological examination, etc.

A CELL LINE derived from human T-CELL LEUKEMIA and used to determine the mechanism of differential susceptibility to anti-cancer drugs and radiation.

A test to determine the ability of an individual to maintain HOMEOSTASIS of BLOOD GLUCOSE. It includes measuring blood glucose levels in a fasting state, and at prescribed intervals before and after oral glucose intake (75 or 100 g) or intravenous infusion (0.5 g/kg).

Ulceration of the GASTRIC MUCOSA due to contact with GASTRIC JUICE. It is often associated with HELICOBACTER PYLORI infection or consumption of nonsteroidal anti-inflammatory drugs (NSAIDS).

More From BioPortfolio on "Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women"

Quick Search


Relevant Topics

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial