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Anti-HIV Drugs During Pregnancy
This study is currently recruiting patients.
| Sponsored by: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
Purpose
The purpose of this study is to determine what doses of anti-HIV medications are appropriate for pregnant women. Anti-HIV medication taken during pregnancy may control a woman's viral load and reduce the chance that the baby will become infected with HIV. Pregnant women may require different doses of anti-HIV drugs than people who are not pregnant. This study will use pharmacokinetic (PK) sampling (a way to find out how drugs act in the body) to determine what doses of which anti-HIV medications are best for HIV infected pregnant women and their infants.
| Condition | Treatment or Intervention |
|---|---|
| HIV Infections |
Drug: Abacavir sulfate Drug: Atazanavir Drug: Didanosine, enteric coated Drug: Emtricitabine Drug: Fosamprenavir Drug: Lopinavir/Ritonavir Drug: Ritonavir Drug: Tenofovir disoproxil fumarate |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Pharmacokinetic Properties of Antiretroviral Drugs During Pregnancy
Expected Total Enrollment: 125
Pregnant women experience unique physiological changes that may result in clinically significant alterations in drug pharmacokinetics. Unfortunately, there have been few clinical trials to study the pharmacokinetics of antiretroviral drugs in pregnant women. The development of appropriate dosing regimens for the HIV infected pregnant woman is critical to the health of both mother and fetus. Overdosing may lead to maternal adverse events and increased risk of fetal toxicity, while underdosing may lead to inadequate virologic control, increased risk of developing drug resistance mutations, and a higher rate of perinatal HIV transmission. This study will develop and evaluate dosing regimens to identify those that are most effective in preventing perinatal HIV transmission and in maintaining the health of both mother and fetus.
Women must be stable on their antiretroviral drug for at least two weeks prior to PK sampling and planning to continue on their current regimen until at least six weeks postpartum. The timing of antiretroviral dosing for the three days prior to and the day of PK sampling must be the same, and must be the same for the PK samplings during pregnancy and postpartum. Intensive PK sampling is performed at study visits during the second or third trimester of pregnancy and again between either 2 and 3 weeks or 6 and 12 weeks postpartum. The timing of antepartum and postpartum PK samplings will vary by drug. On the day of PK sampling, study visits are scheduled to start in the morning, will last 6 to 24 hours, and will coincide with the end of the previous dosing cycle. At the end of the dosing cycle, the morning dose of the antiretroviral drug(s) is given in the clinic after the predose PK sample is drawn. Serial blood collection is performed with an intravenous catheter that is placed in a vein in each patient's arm. Patients having 6- or 12-hour sampling should remain in the clinic until the completion of PK sampling. Patients having 24-hour sampling may leave the clinic following the 12-hour timepoint and return for the 24-hour timepoint.
A urine sample is also collected at each visit and a brief medical interview is performed. An intrapartum PK sample is obtained from the patient and from the detached umbilical cord. The patient and clinical caregiver may decide to modify dosing. If they do so, repeat PK sampling is offered at the new dose. Additionally, women who are on regimens containing ritonavir will undergo a brief medical interview, physical and obstetric exams, and blood collection at entry, every 4 weeks from entry to the 30th week of pregnancy, every 2 weeks from the 30th week of pregnancy to delivery, and every 4 weeks postpartum until the end of the study. They will also undergo an electrocardiogram 4 weeks after they enter the study.
Eligibility
Genders Eligible for Study: Female
Criteria
Inclusion Criteria
Exclusion Criteria
Location
and Contact
Information
More Information
Click here for more information about abacavir sulfate
Click here for more information about atazanavir
Click here for more information about didanosine
Click here for more information about emtricitabine
Click here for more information about fosamprenavir
Click here for more information on lopinavir/ritonavir
Click here for more information on ritonavir
Click here for more information about tenofovir disoproxil fumarate
Click here for more information about HIV and pregnancy.
Haga clic aquí para más información acerca del VIH y el embarazo.
Haga clic aquí para ver información sobre este ensayo clínico en español.
Publications
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