HIV InfectionsNCT00017797
Problems Associated With the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women
An observational study of HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 40 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- HIV Infections, Pregnancy
- How many people
- 160 participants
- Where
- 40 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States39 sites
Univ of Marlyand (Pediatric)
Baltimore, Maryland, 20201
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
Brigham and Womens Hosp
Boston, Massachusetts, 02215
Univ of North Carolina
Chapel Hill, North Carolina, 27514
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
The CORE Ctr
Chicago, Illinois, 60612
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Case Western Reserve Univ
Cleveland, Ohio, 44106
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
The Med Ctr Inc
Columbus, Georgia, 31901
Hutzel Hospital
Detroit, Michigan, 48201-1427
Children's Hosp of Michigan
Detroit, Michigan, 48201
Duke Univ Med Ctr
Durham, North Carolina, 27710
Univ of Hawaii
Honolulu, Hawaii, 96816-2396
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
Wishard Hosp
Indianapolis, Indiana, 46202
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
Univ of Miami (Pediatric)
Miami, Florida, 33161
Hennepin County Med Ctr
Minneapolis, Minnesota, 554145
Univ of Minnesota
Minneapolis, Minnesota, 55455-0392
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
St Peter's Med Ctr
New Brunswick, New Jersey, 08903
Yale University School of Medicine
New Haven, Connecticut, 06504
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Metropolitan Hosp Ctr
New York, New York, 10029
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Univ of Rochester Medical Center
Rochester, New York, 14642
Univ of Washington
Seattle, Washington, 98104
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
Washington Univ (St.Louis)
St Louis, Missouri, 63108-2138
Jacobi Med Ctr
The Bronx, New York, 10016
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
About this study
Official title: Evaluation of Metabolic Complications Associated With Antiretroviral Medications in HIV-1-Infected Pregnant Women
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.
Read the 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.
- Conditions
- HIV Infections, Pregnancy
- Keywords
- Pregnancy Complications, Infectious, HIV-1, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Glucose Intolerance
- Medical subject headings
- HIV Infections, Pregnancy Complications, Infectious, Glucose Intolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 160 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Elizabeth Livingston, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017797
- Sponsor's protocol ID
- ACTG A5084
- Other IDs
- AACTG A5084
- Status last verified
- Aug 2006
- First submitted
- 12 Jun 2001
- Last updated
- 7 Aug 2006
- Results posted
- No
Publications
Livingston EG, Cohn SE, Yang Y, Watts HD, Bardeguez AD, Jones TB, Smith LM, Umbleja T, McComsey GA. Lipids and lactate in human immunodeficiency virus-1 infected pregnancies with or without protease inhibitor-based therapy. Obstet Gynecol. 2007 Aug;110(2 Pt 1):391-7. doi: 10.1097/01.AOG.0000271210.79340.4c.
PubMed 17666616
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metabolic Complications Associated With Antiretroviral Medications in HIV-1-Infected Pregnant Women
- ClinicalTrials.gov ID
- NCT00017797
- Acronym / sponsor ID
- ACTG A5084
- Conditions
- HIV Infections, Pregnancy
- Keywords
- Pregnancy Complications, Infectious, HIV-1, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Glucose Intolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2006.
- Derived from this study: PubMed 17666616Livingston EG, Cohn SE, Yang Y, Watts HD, Bardeguez AD, Jones TB, Smith LM, Umbleja T, McComsey GA. Lipids and lactate in human immunodeficiency virus-1 infected pregnancies with or without protease inhibitor-based therapy. Obstet Gynecol. 2007 Aug;110(2 Pt 1):391-7. doi: 10.1097/01.AOG.0000271210.79340.4c.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Livingston study chair
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 40 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00017797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2006.