HIV InfectionsNCT00000828
Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
An observational study of HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 29 sites in 2 countries.
Trial summary
To identify patterns of zidovudine ( AZT ) susceptibility among mother/infant pairs with perinatal HIV transmission. Most HIV-infected infants acquire their disease via perinatal transmission. Read more about this study
- Who is it for?
- Ages 13 to 60 years, women only
- Conditions the study is for
- HIV Infections, Pregnancy
- How many people
- 250 participants
- Where
- 29 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 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Prior Medication: Required:
- At least 6 months of prior AZT, including continuously during the current pregnancy.
- Patients must have:
- HIV seropositivity.
- CD4 count <= 300 cells/mm3.
- Gestational age of 20-36 weeks, with intention to carry pregnancy to term.
- At least 6 months of prior AZT therapy, including continuous AZT therapy during the current pregnancy.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Evidence of pre-existing fetal anomalies that would preclude survival to the end of the study, such as anencephaly, renal agenesis, or Potter's syndrome.
- Concurrent Medication:
- Excluded:
- Antiretrovirals other than AZT.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States28 sites
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
Children's Hosp of Boston
Boston, Massachusetts, 021155724
Brigham and Women's Hosp
Boston, Massachusetts, 02115
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
Columbus Children's Hosp
Columbus, Ohio, 432052696
Duke Univ Med Ctr
Durham, North Carolina, 277103499
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
Connecticut Children's Med Ctr - Pediatric
Hartford, Connecticut, 06106
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
Univ of Miami (Pediatric)
Miami, Florida, 33161
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
Univ Hosp
New Orleans, Louisiana, 70112
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Mount Sinai Med Ctr / Pediatrics
New York, New York, 10029
Columbia Presbyterian Med Ctr
New York, New York, 10032
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, 10032
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
Univ of Rochester Medical Center
Rochester, New York, 14642
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
About this study
To identify patterns of zidovudine ( AZT ) susceptibility among mother/infant pairs with perinatal HIV transmission.
Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies.
Read the detailed description
Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies.
HIV-infected pregnant women are enrolled at 20-36 weeks gestation. Patients have blood drawn for HIV culture at study entry and at delivery. Infants have blood drawn for HIV culture at delivery and at 1, 3, 6, and 18 months of age.
- Conditions
- HIV Infections, Pregnancy
- Keywords
- Pregnancy, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Drug Resistance, Microbial, Disease Transmission, Vertical
- Medical subject headings
- HIV Infections, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
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 (4)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
- Enrolment
- 250 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Bardeguez AD, Study chairPitt J, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000828
- Sponsor's protocol ID
- ACTG 255
- Status last verified
- Oct 1997
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Bardeguez AD. Management of HIV infection for the childbearing age woman. Clin Obstet Gynecol. 1996 Jun;39(2):344-60. doi: 10.1097/00003081-199606000-00009. No abstract available.
PubMed 8734001Bardeguez AD, Taylor U, Appuzio J, Leus C, Lister M, Denny T, Palumbo P, Connor E. Characteristics of pregnant women infected with human immunodeficiency virus 1: Newark perinatal transmission study. Int Conf AIDS. 1991 Jun 16-21;7(2):193 (abstract no WB2044)
Japour AJ, Welles S, McIntosh K, Colson A, Chung P, Lockman S, Davenny K, Fowler MG, Hansen IC, Kalish L, Moye J, Rick K, Zorilla C, Pitt J. ZDV resistance (ZDVR) mutations in ZDV exposed mother infant pairs: preliminary findings from the women and infants transmission study (WITS). Int Conf AIDS. 1996 Jul 7-12;11(1):370 (abstract no TuC2606)
Garcia PM, Kalish LA, Pitt J, Minkoff H, Quinn TC, Burchett SK, Kornegay J, Jackson B, Moye J, Hanson C, Zorrilla C, Lew JF. Maternal levels of plasma human immunodeficiency virus type 1 RNA and the risk of perinatal transmission. Women and Infants Transmission Study Group. N Engl J Med. 1999 Aug 5;341(6):394-402. doi: 10.1056/NEJM199908053410602.
PubMed 10432324
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
- ClinicalTrials.gov ID
- NCT00000828
- Acronym / sponsor ID
- ACTG 255
- Conditions
- HIV Infections, Pregnancy
- Keywords
- Pregnancy, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Drug Resistance, Microbial, Disease Transmission, Vertical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- 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.
To identify patterns of zidovudine ( AZT ) susceptibility among mother/infant pairs with perinatal HIV transmission.
Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies.
Detailed description
Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies.
HIV-infected pregnant women are enrolled at 20-36 weeks gestation. Patients have blood drawn for HIV culture at study entry and at delivery. Infants have blood drawn for HIV culture at delivery and at 1, 3, 6, and 18 months of age.
Study design
Who may qualify
- Ages
- 13 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- At least 6 months of prior AZT, including continuously during the current pregnancy.
- HIV seropositivity.
- CD4 count <= 300 cells/mm3.
- Gestational age of 20-36 weeks, with intention to carry pregnancy to term.
- At least 6 months of prior AZT therapy, including continuous AZT therapy during the current pregnancy.
Key exclusion criteria (6 listed)
- Evidence of pre-existing fetal anomalies that would preclude survival to the end of the study, such as anencephaly, renal agenesis, or Potter's syndrome.
- Antiretrovirals other than AZT.
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 24 Jun 2005.
- Background: PubMed 8734001Bardeguez AD. Management of HIV infection for the childbearing age woman. Clin Obstet Gynecol. 1996 Jun;39(2):344-60. doi: 10.1097/00003081-199606000-00009. No abstract available.
- BackgroundBardeguez AD, Taylor U, Appuzio J, Leus C, Lister M, Denny T, Palumbo P, Connor E. Characteristics of pregnant women infected with human immunodeficiency virus 1: Newark perinatal transmission study. Int Conf AIDS. 1991 Jun 16-21;7(2):193 (abstract no WB2044)
- BackgroundJapour AJ, Welles S, McIntosh K, Colson A, Chung P, Lockman S, Davenny K, Fowler MG, Hansen IC, Kalish L, Moye J, Rick K, Zorilla C, Pitt J. ZDV resistance (ZDVR) mutations in ZDV exposed mother infant pairs: preliminary findings from the women and infants transmission study (WITS). Int Conf AIDS. 1996 Jul 7-12;11(1):370 (abstract no TuC2606)
- Background: PubMed 10432324Garcia PM, Kalish LA, Pitt J, Minkoff H, Quinn TC, Burchett SK, Kornegay J, Jackson B, Moye J, Hanson C, Zorrilla C, Lew JF. Maternal levels of plasma human immunodeficiency virus type 1 RNA and the risk of perinatal transmission. Women and Infants Transmission Study Group. N Engl J Med. 1999 Aug 5;341(6):394-402. doi: 10.1056/NEJM199908053410602.
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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.
Bardeguez AD study chair
Pitt J study chair
29 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 29 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 6 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 NCT00000828, which also lists 4 linked publications.
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 24 Jun 2005.