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Problems Associated With the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00017797
First received: June 12, 2001
Last updated: August 3, 2006
Last verified: August 2006
  Purpose

The purpose of this study is to find out if HIV-infected pregnant women who take protease inhibitors (PIs) are more likely to have blood sugar problems than those who do not take PIs.

HIV-infected people generally are treated with a combination of different types of anti-HIV drugs, 1 of which is usually a PI. The same holds true for pregnant women, but not much is known about the use of these drugs in pregnancy. Blood sugar and liver problems caused by anti-HIV drugs in nonpregnant patients are well known but their effects in pregnancy are not. Also, certain physical changes brought about by pregnancy may affect the way drugs are handled in the body. There remains a need for further study into the use of anti-HIV drugs during pregnancy and their effect on the safety of the mother and baby.


Condition
HIV Infections
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Evaluation of Metabolic Complications Associated With Antiretroviral Medications in HIV-1-Infected Pregnant Women

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 160
Detailed Description:

The dramatic impact of potent combination antiretroviral therapies on the course of HIV disease has made the use of PIs routine in the care of HIV-1-infected individuals. Combination therapy likewise has become the standard of care in pregnant individuals, even though information on use of these drugs during human pregnancy is limited. There are no published prospective evaluations of toxicities experienced by pregnant women on PI-containing antiretroviral regimens, despite findings of metabolic disturbances of glucose, fatty acids, and cholesterol, as well as lactic acidosis/hepatic steatosis in nonpregnant individuals treated with antiretrovirals. Gastrointestinal (GI) side effects also are well documented in nonpregnant individuals treated with PIs, but have not been systematically evaluated in pregnancy. In addition, the physiologic changes brought about by pregnancy may influence the pharmacokinetics, safety, and side effects of antiretroviral drugs. There remains a need for further evaluation of the use of antiretrovirals during pregnancy and their impact on maternal, fetal, and infant safety.

Patients are stratified according to whether or not they are on a PI-containing antiretroviral regimen and the number of weeks of gestation (26 weeks or less versus greater than 26 weeks). Patients are followed at 8-week intervals from the time of entry until delivery or pregnancy termination, with an additional visit at 12 weeks after delivery or pregnancy termination. All infants born to study participants are evaluated at the time of delivery (anthropometrics and HIV DNA PCR) and are seen again at the mothers' 12-week post-delivery visit. Glucose tolerance testing and other metabolic studies are performed serially during pregnancy and again postpartum. This is an observational study and drugs are not supplied. Patients receiving antiretroviral therapy must obtain their own medications.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Are female and 13 years of age or older.
  • Are between 20 and 34 weeks pregnant at study entry.
  • Had an ultrasound performed at 16 or more weeks of pregnancy.
  • Have consent of a parent or guardian if under 18 years of age. The father of the baby, if available, also must give consent.
  • Have taken the same anti-HIV drugs, including a PI, during the 8 weeks just before study entry. If not taking a PI or any anti-HIV drug, must not have taken a PI during the 8 weeks just before study entry. Patients must carry on this way for the entire study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have diabetes. Patients who have had diabetes caused by pancreas problems or steroid use in the past, but now have normal blood sugar without having to take drugs or special diets, are allowed. Patients who have had blood sugar problems in a past pregnancy also are allowed.
  • Had a serious infection or medical condition within 30 days before study entry.
  • Are enrolled in another study which requires a lot of blood tests.
  • Take, or have taken in the 6 weeks before study entry, any of the following drugs: hormones (growth hormone, testosterone, or steroids), thalidomide, interleukins or interferons, efavirenz, hydroxyurea, drugs to control blood sugar, and anti-cancer drugs.
  • Take, or have taken in the year before study entry, steroids, e.g., prednisone, for more than 14 days in any 3-month period. Inhaled steroids and steroid creams/ointments are allowed.
  • Take, or have taken in the 30 days before study entry, PIs with lovastatin or simvastatin (2 drugs that lower the amount of fat in the blood).
  • Have an ultrasound showing a major abnormality in the baby.
  • Have problems with their pregnancy and/or are expecting more than 1 baby.
  • Abuse drugs or alcohol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017797

  Show 40 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Elizabeth Livingston
  More Information

No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00017797     History of Changes
Other Study ID Numbers: ACTG A5084, AACTG A5084
Study First Received: June 12, 2001
Last Updated: August 3, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Pregnancy Complications, Infectious
HIV-1
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Glucose Intolerance

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Reverse Transcriptase Inhibitors
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014