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AzTrials

HIV InfectionsNCT00041964

A Study of HIV Levels During Pregnancy and After Childbirth

An observational study of HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 32 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find out if HIV-infected pregnant women taking anti-HIV drugs have an increased amount of HIV in their blood (viral load) after having the baby. The purpose of A5153s, a substudy of A5150, is to characterize two anti-HIV drugs (nelfinavir [NFV] and lopinavir/ritonavir [LPV/r]) in… 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
129 participants
Where
32 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 age 13 or older.
  • Are between 22 and 30 weeks pregnant.
  • Have had their pregnancy confirmed by ultrasound at 14 weeks gestation or later.
  • Are infected with HIV.
  • Are planning to receive at least 8 weeks of highly active antiretroviral therapy (HAART) by the time they have their baby.
  • Are available for follow-up for the duration of the study.

Who cannot join

  • Patients may not be eligible for this study if they:
  • Intend to terminate their pregnancy.
  • Intend to breast-feed their baby.
  • Are carrying a baby with major abnormalities, including spina bifida, anencephaly, hydrops, or ascites.
  • Have taken certain medications.
  • Are enrolled in other studies that require large blood draws.
  • Will be taking anti-HIV drugs only to prevent mother-to-child transmission of HIV, and not to treat the maternal infection itself.
  • Actively abuse drugs or alcohol in a way that would interfere with participation in the study.

Trial locations and contacts

32 sites in 2 countries.

32 sites in 2 countries

United States31 sites

  • Emory Univ

    Atlanta, Georgia, 30308

  • Univ of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Univ of North Carolina

    Chapel Hill, North Carolina, 27514

  • Northwestern University

    Chicago, Illinois, 60611-3015

  • Cook County Hosp Core Ctr

    Chicago, Illinois, 60612

  • Rush Presbyterian - Saint Luke's Med Ctr

    Chicago, Illinois, 60612

  • Chicago Childrens Memorial Hospital (Pediatric)

    Chicago, Illinois, 60614

  • Case Western Reserve Univ

    Cleveland, Ohio, 44106

  • MetroHealth Med Ctr

    Cleveland, Ohio, 44109-1998

  • University of Texas, Southwestern Medical Center

    Dallas, Texas, 75235-9173

  • Hutzel Hospital

    Detroit, Michigan, 48201-1427

  • Childrens Hospital of Michigan

    Detroit, Michigan, 48201

  • Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • University of Hawaii

    Honolulu, Hawaii, 98616-2396

  • Indiana Univ Hosp

    Indianapolis, Indiana, 46202

  • Univ of Florida- Health Science Ctr

    Jacksonville, Florida, 32209

  • Los Angeles County Medical Center/USC

    Los Angeles, California, 90033

  • UCLA School of Medicine

    Los Angeles, California, 90095-1793

  • The Regional Med Ctr, Memphis

    Memphis, Tennessee, 38105-2794

  • Hennepin County Med Clinic

    Minneapolis, Minnesota, 55455-0392

  • Comprehensive Care Clinic

    Nashville, Tennessee, 37203

  • NYU/Bellevue

    New York, New York, 10016-6481

  • Columbia University

    New York, New York, 10032-3784

  • Univ of Med & Dentistry of NJ/Univ Hosp

    Newark, New Jersey, 07103

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213-2582

  • Miriam Hosp / Brown Univ

    Providence, Rhode Island, 02906

  • UCSD Mother, Child & Adolescent HIV Program

    San Diego, California, 92103

  • San Francisco General Hosp

    San Francisco, California, 94110

  • Univ of Washington (Seattle)

    Seattle, Washington, 98104

  • State Univ of New York at Stony Brook

    Stony Brook, New York, 11794-8111

  • Jacobi Med Ctr

    The Bronx, New York, 10461

Other trials in United States

Puerto Rico1 site

  • San Juan City Hosp

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Prospective Observational Study of Virologic and Immunologic Changes in HIV-Infected Women During the Postpartum Period

The purpose of this study is to find out if HIV-infected pregnant women taking anti-HIV drugs have an increased amount of HIV in their blood (viral load) after having the baby.

The purpose of A5153s, a substudy of A5150, is to characterize two anti-HIV drugs (nelfinavir [NFV] and lopinavir/ritonavir [LPV/r]) in HIV-infected women during pregnancy and after childbirth.

Sometimes pregnant women have an increase in their HIV viral load after their baby is born. This study will try to find out how often this happens. It will also examine possible reasons why the increase in viral load occurs.

Read the detailed description

Limited data suggest that HIV-infected pregnant women develop postpartum viral rebound. However, viral load changes in the postpartum period have not been adequately characterized. Changes in adherence to antiretroviral therapy, pregnancy-related changes in pharmacokinetics of antiretroviral medications, and decline in immune competence are mechanisms by which postpartum viral load rebound may occur. This study is designed to characterize the incidence and magnitude of postpartum viral rebound during the initial 24 weeks postpartum and to explore the mechanisms and consequences of viral rebound.

Eligible patients are evaluated at gestational weeks 34 and 36, at delivery, and at regular visits for 96 weeks postpartum. Most evaluations include a medical history, physical exam, laboratory tests, and adherence and quality-of-life questionnaires. Viral load and CD4/CD8 cell counts are measured frequently.

Patients are expected to receive at least 8 weeks of stable HAART before delivery, and to continue HAART throughout the remainder of the study. The choice of HAART is left to the primary provider. No antiretroviral drugs are provided by this study.

Patients participating in the A5153s substudy receive either NFV or LPV/r as part of their HAART. Pharmacokinetic blood sampling takes place at 36 weeks gestation, 6 weeks postpartum, and 24 weeks postpartum. Patients record the administration times and doses of their NFV or LPV/r for 48 hours prior to each substudy visit, and hold their regularly scheduled doses of antiretroviral medications on substudy days. Patients arrive at the clinic fasting (no food or drink for the previous 8 hours) and are given a standardized breakfast prior to supervised administration of their NFV or LPV/r dose. An intravenous catheter is placed in an arm vein for blood collection at pre-dose and 1, 2, 4, and 6 hours post-dose.

Keywords
Lopinavir, Pregnancy Trimester, Third, Pregnancy Complications, Infectious, HIV Protease Inhibitors, Ritonavir, Nelfinavir, Viral Load, puerperium
Medical subject headings
HIV Infections, Pregnancy Complications, Infectious

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2002 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
129 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00041964
Sponsor's protocol ID
ACTG A5150
Other IDs
ACTG A5153s, AACTG A5150, AACTG A5153s
Status last verified
Jul 2012
First submitted
19 Jul 2002
Last updated
24 Jul 2012
Results posted
No

Publications

  • Melvin AJ, Burchett SK, Watts DH, Hitti J, Hughes JP, McLellan CL, King PD, Johnson EJ, Williams BL, Frenkel LM, Coombs RW. Effect of pregnancy and zidovudine therapy on viral load in HIV-1-infected women. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Mar 1;14(3):232-6. doi: 10.1097/00042560-199703010-00006.

    PubMed 9117455

  • Rich KC, Siegel JN, Jennings C, Rydman RJ, Landay AL. CD4+ lymphocytes in perinatal human immunodeficiency virus (HIV) infection: evidence for pregnancy-induced immune depression in uninfected and HIV-infected women. J Infect Dis. 1995 Nov;172(5):1221-7. doi: 10.1093/infdis/172.5.1221.

    PubMed 7594657

  • Cao Y, Krogstad P, Korber BT, Koup RA, Muldoon M, Macken C, Song JL, Jin Z, Zhao JQ, Clapp S, Chen IS, Ho DD, Ammann AJ. Maternal HIV-1 viral load and vertical transmission of infection: the Ariel Project for the prevention of HIV transmission from mother to infant. Nat Med. 1997 May;3(5):549-52. doi: 10.1038/nm0597-549.

    PubMed 9142125

  • Burns DN, Landesman S, Minkoff H, Wright DJ, Waters D, Mitchell RM, Rubinstein A, Willoughby A, Goedert JJ. The influence of pregnancy on human immunodeficiency virus type 1 infection: antepartum and postpartum changes in human immunodeficiency virus type 1 viral load. Am J Obstet Gynecol. 1998 Feb;178(2):355-9. doi: 10.1016/s0002-9378(98)80025-2.

    PubMed 9500499

  • Sha BE, Tierney C, Cohn SE, Sun X, Coombs RW, Frenkel LM, Kalams SA, Aweeka FT, Bastow B, Bardeguez A, Kmack A, Stek A; Aids Clinical Trials Group ACTG A5150 Team. Postpartum viral load rebound in HIV-1-infected women treated with highly active antiretroviral therapy: AIDS Clinical Trials Group Protocol A5150. HIV Clin Trials. 2011 Jan-Feb;12(1):9-23. doi: 10.1310/hct1201-9.

    PubMed 21388937

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 32 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 8 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 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 NCT00041964, which also lists 5 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 Jul 2012.

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