HIV InfectionsPhase 1NCT00001106
A Study of Zidovudine in HIV-Infected Pregnant Women and Their Children
A Phase 1 study testing Zidovudine in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.
Trial summary
AMENDED: To evaluate the pharmacokinetics of intravenously administered AZT to HIV-1 infected pregnant women in labor; to evaluate the pharmacokinetics and urinary excretion of AZT and its metabolites in newborns of HIV-1 infected mothers who receive IV AZT only during labor; to evaluate the safety of IV AZT… Read more about this study
- Who is it for?
- Ages 1 day to 50 years
- Conditions the study is for
- HIV Infections, Pregnancy
- What is being tested?
- Zidovudine
- How many people
- 40 participants
- Where
- 9 sitesUnited States
- Study dates
- Start not givento Mar 1994
- Phase
- Phase 1
- 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 1 day to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- In one group of four or more patients, methadone maintenance treatment.
- Acetaminophen for periods less than 72 hours.
- Supportive therapy including blood and blood products, vaginal creams, antiemetics, antidiarrheals, and cough medicines as deemed necessary by the responsible investigator.
- Iron, multivitamins, and short course of treatment for correctable medical problems, such as urinary tract infection.
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- Concurrent Treatment:
- Allowed:
- Blood and blood products as supportive therapy.
- Patients must have HIV-1 infection and be in the third trimester of pregnancy. Additional patients will also be receiving methadone maintenance therapy for intravenous drug use.
Who cannot join
- Concurrent Medication:
- Excluded:
- Systemic medications during this pregnancy.
- Acetaminophen for periods more than 72 hours.
- Patients will be excluded from the study for the following reasons:
- Complications of pregnancy.
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- History of poor medical compliance related to factors other than accessibility of care.
- Insistence on breast-feeding during the first 24 hours of the birth of the child.
- Evidence of preexisting fetal anomalies at = or > 20 weeks gestation as noted by an abnormal level 2 sonogram prior to study entry.
- Evidence of fetal intolerance of the intrauterine environment including intrauterine growth retardation, oligohydramnios, polyhydramnios, biophysical profile equal to or less than 6 for fetus with a gestational age > 32 weeks, congenital malformation, fetal hydrous or ascites.
- Previous systemic infection including influenza during this pregnancy.
- Malabsorption syndrome and/or history of frequent diarrhea that might interfere with absorption of oral zidovudine (AZT).
- Prior Medication:
- Excluded:
- Antivirals and other systemic medications during this pregnancy.
- Patients may not have any of the following diseases or symptoms:
- Obstetrical complications:
- Poor obstetrical history including but not limited to recurrent spontaneous abortions, previous preterm or low-birth-weight infant, congenital anomalies (past or present pregnancy), premature rupture of membranes, multiple gestation, intrauterine fetal death (this pregnancy), and placenta previa or abruptio (this pregnancy).
- Medical complications:
- Conditions including but not limited to insulin-dependent diabetes mellitus (IDDM), hypertensive disorders which include preeclampsia, eclampsia, chronic hypertension, cardiovascular disease including rheumatic or congenital heart disease, collagen vascular disease, endocarditis, and renal disease.
- Hematologic complications.
- Neurologic complications.
- Pulmonary complications.
- History of illicit drug use during this pregnancy.
- Note: This exclusion applies only to the first six or more women to enter this study who do not have a history of intravenous drug use.
- Four or more patients:
- Intravenous drug use, if enrolled in a methadone maintenance program.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
Kaiser - Edgemont Street / UCLA Med Ctr
Los Angeles, California, 900951752
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
Univ of Miami (Pediatric)
Miami, Florida, 33161
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
UMDNJ - New Jersy Med School
Newark, New Jersey, 071032714
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
Children's Hosp of Seattle
Seattle, Washington, 98105
Univ of Washington
Seattle, Washington, 981224304
About this study
Official title: A Phase I Trial To Evaluate Zidovudine (ZDV) in HIV-1 Infected Pregnant Women and Their Offspring
AMENDED: To evaluate the pharmacokinetics of intravenously administered AZT to HIV-1 infected pregnant women in labor; to evaluate the pharmacokinetics and urinary excretion of AZT and its metabolites in newborns of HIV-1 infected mothers who receive IV AZT only during labor; to evaluate the safety of IV AZT administered by continuous infusion to HIV-1 infected laboring women and their infants. Original design: To determine the distribution and elimination of zidovudine (AZT) in the body as well as its safety in the treatment of pregnant women and their unborn children. The information derived from this study is required in order to design a future study that will assess the efficacy of AZT in reducing the transmission rate of HIV-1 from seropositive women to their fetus by treating them during the third trimester of pregnancy.
An estimated 30 percent to 40 percent infected pregnant women risk transmission of HIV-1 to their infants, whether they be symptomatic or asymptomatic. Zidovudine (AZT) has previously demonstrated its effectiveness as a potent inhibitor of HIV replication in vitro and in adult patients; benefits of treatment include decreased mortality rate, decreased incidence of opportunistic infections, and increased number of CD4 cells. Phase I AZT studies in children, however, have resulted in uncontrolled information regarding clinical efficacy. The present study, therefore, will investigate the safety and pharmacokinetics of intravenous (IV) and oral AZT administration to HIV-1 infected pregnant women in the 3rd trimester, as well as the safety and efficacy of such treatment in their newborns.
It is hoped that the results will be instrumental in designing future studies to assess the efficacy of AZT in reducing the transmission risk of HIV-1.
Read the detailed description
An estimated 30 percent to 40 percent infected pregnant women risk transmission of HIV-1 to their infants, whether they be symptomatic or asymptomatic. Zidovudine (AZT) has previously demonstrated its effectiveness as a potent inhibitor of HIV replication in vitro and in adult patients; benefits of treatment include decreased mortality rate, decreased incidence of opportunistic infections, and increased number of CD4 cells. Phase I AZT studies in children, however, have resulted in uncontrolled information regarding clinical efficacy. The present study, therefore, will investigate the safety and pharmacokinetics of intravenous (IV) and oral AZT administration to HIV-1 infected pregnant women in the 3rd trimester, as well as the safety and efficacy of such treatment in their newborns.
It is hoped that the results will be instrumental in designing future studies to assess the efficacy of AZT in reducing the transmission risk of HIV-1.
AMENDED: For the pharmacokinetic and safety study of AZT during labor and in the newborn infants, women who were screened and have consented are included in this part of the study. 6 mother-infant pairs without a history of intravenous drug abuse and 4 pairs with such a history are evaluated. The mother receives an infusion of AZT over 1 hour followed by continuous infusion of AZT for at least 4 hours until delivery. Pharmacokinetic data is collected on all patients including those who deliver before receiving 4 hours of AZT infusion.
AMENDED: The trial will proceed as described above except that the first 2 methadone patients enrolled will receive half the AZT dose given to the non-methadone patients. Results will be evaluated before dosing of additional methadone-use patients is done. Original design: Following evaluation, patients receive one intravenous dose of AZT over a 1-hour period. One day later, patients begin taking AZT capsules 5 times a day by mouth for the remaining weeks prior to labor.
During labor, patients continue to receive AZT intravenously every 4 hours until they deliver their babies. Blood and urine tests are made to measure the amounts of AZT in the mother's and, after delivery, the baby's body fluids. AZT is stopped after the baby has been delivered. The initial enrollment is six women with no history of intravenous drug abuse plus another four women with a history of intravenous drug use, who have been receiving methadone maintenance therapy. These women are not required to have a negative urine toxicology screen for illicit drugs to enter the study.
- Conditions
- HIV Infections, Pregnancy
- Being tested
- Zidovudine
- Keywords
- Pregnancy, Pregnancy Complications, Infectious, Prenatal Exposure Delayed Effects, Drug Evaluation, Acquired Immunodeficiency Syndrome, Zidovudine
- Medical subject headings
- HIV Infections, Pregnancy Complications, Infectious, Prenatal Exposure Delayed Effects, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidovudineDrug
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)
- Study completionMar 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- O'Sullivan MJ, Study chairParks W, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001106
- Sponsor's protocol ID
- ACTG 082
- Other IDs
- 11057
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial To Evaluate Zidovudine (ZDV) in HIV-1 Infected Pregnant Women and Their Offspring
- ClinicalTrials.gov ID
- NCT00001106
- Acronym / sponsor ID
- ACTG 082
- Conditions
- HIV Infections, Pregnancy
- Keywords
- Pregnancy, Pregnancy Complications, Infectious, Prenatal Exposure Delayed Effects, Drug Evaluation, Acquired Immunodeficiency Syndrome, Zidovudine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Mar 1994 (actual)
- 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.
AMENDED: To evaluate the pharmacokinetics of intravenously administered AZT to HIV-1 infected pregnant women in labor; to evaluate the pharmacokinetics and urinary excretion of AZT and its metabolites in newborns of HIV-1 infected mothers who receive IV AZT only during labor; to evaluate the safety of IV AZT administered by continuous infusion to HIV-1 infected laboring women and their infants. Original design: To determine the distribution and elimination of zidovudine (AZT) in the body as well as its safety in the treatment of pregnant women and their unborn children. The information derived from this study is required in order to design a future study that will assess the efficacy of AZT in reducing the transmission rate of HIV-1 from seropositive women to their fetus by treating them during the third trimester of pregnancy.
An estimated 30 percent to 40 percent infected pregnant women risk transmission of HIV-1 to their infants, whether they be symptomatic or asymptomatic. Zidovudine (AZT) has previously demonstrated its effectiveness as a potent inhibitor of HIV replication in vitro and in adult patients; benefits of treatment include decreased mortality rate, decreased incidence of opportunistic infections, and increased number of CD4 cells. Phase I AZT studies in children, however, have resulted in uncontrolled information regarding clinical efficacy. The present study, therefore, will investigate the safety and pharmacokinetics of intravenous (IV) and oral AZT administration to HIV-1 infected pregnant women in the 3rd trimester, as well as the safety and efficacy of such treatment in their newborns.
It is hoped that the results will be instrumental in designing future studies to assess the efficacy of AZT in reducing the transmission risk of HIV-1.
Detailed description
An estimated 30 percent to 40 percent infected pregnant women risk transmission of HIV-1 to their infants, whether they be symptomatic or asymptomatic. Zidovudine (AZT) has previously demonstrated its effectiveness as a potent inhibitor of HIV replication in vitro and in adult patients; benefits of treatment include decreased mortality rate, decreased incidence of opportunistic infections, and increased number of CD4 cells. Phase I AZT studies in children, however, have resulted in uncontrolled information regarding clinical efficacy. The present study, therefore, will investigate the safety and pharmacokinetics of intravenous (IV) and oral AZT administration to HIV-1 infected pregnant women in the 3rd trimester, as well as the safety and efficacy of such treatment in their newborns.
It is hoped that the results will be instrumental in designing future studies to assess the efficacy of AZT in reducing the transmission risk of HIV-1.
AMENDED: For the pharmacokinetic and safety study of AZT during labor and in the newborn infants, women who were screened and have consented are included in this part of the study. 6 mother-infant pairs without a history of intravenous drug abuse and 4 pairs with such a history are evaluated. The mother receives an infusion of AZT over 1 hour followed by continuous infusion of AZT for at least 4 hours until delivery. Pharmacokinetic data is collected on all patients including those who deliver before receiving 4 hours of AZT infusion.
AMENDED: The trial will proceed as described above except that the first 2 methadone patients enrolled will receive half the AZT dose given to the non-methadone patients. Results will be evaluated before dosing of additional methadone-use patients is done. Original design: Following evaluation, patients receive one intravenous dose of AZT over a 1-hour period. One day later, patients begin taking AZT capsules 5 times a day by mouth for the remaining weeks prior to labor.
During labor, patients continue to receive AZT intravenously every 4 hours until they deliver their babies. Blood and urine tests are made to measure the amounts of AZT in the mother's and, after delivery, the baby's body fluids. AZT is stopped after the baby has been delivered. The initial enrollment is six women with no history of intravenous drug abuse plus another four women with a history of intravenous drug use, who have been receiving methadone maintenance therapy. These women are not required to have a negative urine toxicology screen for illicit drugs to enter the study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- In one group of four or more patients, methadone maintenance treatment.
- Acetaminophen for periods less than 72 hours.
- Supportive therapy including blood and blood products, vaginal creams, antiemetics, antidiarrheals, and cough medicines as deemed necessary by the responsible investigator.
- Iron, multivitamins, and short course of treatment for correctable medical problems, such as urinary tract infection.
- Blood and blood products as supportive therapy.
Key exclusion criteria (27 listed)
- Systemic medications during this pregnancy.
- Acetaminophen for periods more than 72 hours.
- Complications of pregnancy.
- History of poor medical compliance related to factors other than accessibility of care.
- Insistence on breast-feeding during the first 24 hours of the birth of the child.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zidovudine | Drug | – |
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 1 Nov 2021.
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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.
O'Sullivan MJ study chair
Parks W study chair
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zidovudine in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.
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 10 inclusion and 27 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 1 Nov 2021.