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Pregnancy drug study aims to Fine-Tune HIV and TB treatment

NCT ID NCT00042289

Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how HIV and tuberculosis (TB) medications are processed in the bodies of pregnant women and their newborns. Researchers measured drug levels in blood and vaginal fluids to see if dosing needs to change during pregnancy and after birth. Over 1,500 women took part, helping doctors understand how to keep both mother and baby safe while treating these infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,578 people

The number who actually took part.

Started

Jun 2003

Finished

Sep 2020

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant and postpartum women from IMPAACT US and non-US sites receiving the medicines specified in the protocol as part of clinical care and infants born to those women enrolled during pregnancy.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Maternal Inclusion Criteria: * Participant must belong to one of the following 5 groups: 1. HIV-infected pregnant women greater than or equal to 20 weeks gestation NOT on TB treatment receiving one or more of the ARV drugs/drug combinations specified in the protocol 2. HIV-infected pregnant women greater than or equal to 20 weeks gestation receiving one of the ARV drugs/drug combinations specified in the protocol and TB treatment with at least one of the TB drugs, specified in the protocol, at study entry 3. HIV-uninfected pregnant women greater than or equal to 20 weeks gestation receiving at least two of the first-line TB drugs, specified in the protocol, at study entry 4. HIV-infected and HIV-uninfected pregnant women greater than or equal to 20 weeks gestation receiving at least two of the second-line TB drugs, specified in the protocol, at study entry 5. HIV-infected women 2 to 12 weeks (14 to 84 days) post-delivery receiving one of the ARV drug combinations listed in the protocol AND starting postpartum contraceptives as listed in the protocol * The woman must be stable on the ARV drug/drug combination and/or TB drug combination for at least 2 weeks prior to PK sampling * If a woman is receiving a specific generic ARV formulation, the protocol team has approved this formulation * HIV-infected pregnant women must be planning to continue on current ARV regimen until postpartum PK sampling is completed. HIV-infected postpartum women on hormonal contraceptives must be planning to continue on ARV and contraceptive regimens until final PK sampling is completed * For HIV-infected women: confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry. More information on this criterion can be found in the protocol. * HIV-uninfected pregnant women must have documented negative HIV antibody test during current pregnancy. Note: adequate source documentation, including the date of specimen collection, date of testing, test performed, and test result, must be available. * Participants enrolling in the 3rd trimester must enroll by 37 6/7 weeks gestation * Participant can provide legal informed consent per local regulations * If a woman has completed this study and becomes pregnant again, she may re-enroll in the study only if she is enrolled in a different arm than that studied during her initial enrollment Maternal Exclusion Criteria: * Women on medicines known to interfere with absorption, metabolism, or clearance of the drug being evaluated (see protocol for more information). Rifampicin is permitted for women being evaluated for TB and ARV drug interactions * If pregnant, carrying multiple fetuses * Clinical or laboratory toxicity that, in the opinion of the site investigator, would be likely to require a change in the medicine regimen during the period of study Infant Enrollment Criteria: \- All infants of mothers enrolled during pregnancy (meeting criteria specified above) are enrolled, in utero, immediately after maternal enrollment. Infant Requirements for Washout Pharmacokinetic Sampling: * Born to HIV-infected mother enrolled during pregnancy in an ARV arm (does not include infants born to HIV-uninfected mothers receiving TB drugs) * Birth weight greater than 1000 grams * Is NOT receiving disallowed medications described in Section 7 of the protocol * Does not have any severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by the site investigator * Born after singleton delivery (not after multiple birth)

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Conditions

The condition(s) this trial relates to.

HIV infectious disease tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections

Contacts and locations

Locations

  • Baystate Health, Baystate Med. Ctr.

    Springfield, Massachusetts, 01199, United States

  • Bhumibol Adulyadej Hosp. CRS

    Sai Mai, Bangkok, 10220, Thailand

  • Boston Medical Center Ped. HIV Program NICHD CRS

    Boston, Massachusetts, 02118, United States

  • Bronx-Lebanon Hospital Center NICHD CRS

    The Bronx, New York, 10457, United States

  • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

    Chiang Mai, 50200, Thailand

  • Chiangrai Prachanukroh Hospital NICHD CRS

    Chiang Mai, 50100, Thailand

  • Children's Hosp. of Boston NICHD CRS

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Michigan NICHD CRS

    Detroit, Michigan, 48201, United States

  • Chonburi Hosp. CRS

    Chon Buri, 20000, Thailand

  • Columbia IMPAACT CRS

    New York, New York, 10032, United States

  • DUMC Ped. CRS

    Durham, North Carolina, 27710, United States

  • David Geffen School of Medicine at UCLA NICHD CRS

    Los Angeles, California, 90095-1752, United States

  • Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS

    Cape Town, Western Cape, 7505, South Africa

  • Emory University School of Medicine NICHD CRS

    Atlanta, Georgia, 30322, United States

  • Famcru Crs

    Tygerberg, Western Cape, 7505, South Africa

  • Gaborone CRS

    Gaborone, South-East District, Botswana

  • Harbor UCLA Medical Ctr. NICHD CRS

    Torrance, California, 90502, United States

  • Hosp. General de Agudos Buenos Aires Argentina NICHD CRS

    Ciudad de Buenos Aires, Buenos Aires, C1221ADC, Argentina

  • Hosp. Geral De Nova Igaucu Brazil NICHD CRS

    Rio de Janeiro, 26030, Brazil

  • Hosp. Santa Casa Porto Alegre Brazil NICHD CRS

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Hosp. dos Servidores Rio de Janeiro NICHD CRS

    Rio de Janeiro, 20221-903, Brazil

  • Hospital Federal dos Servidores do Estado NICHD CRS

    Rio de Janeiro, 20221-903, Brazil

  • IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS

    San Juan, 00935, Puerto Rico

  • Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS

    Rio de Janeiro, 21941-612, Brazil

  • Jacobi Med. Ctr. Bronx NICHD CRS

    The Bronx, New York, 10461, United States

  • Johns Hopkins Univ. Baltimore NICHD CRS

    Baltimore, Maryland, 21287, United States

  • Kilimanjaro Christian Medical Centre (KCMC)

    Moshi, Tanzania

  • Lurie Children's Hospital of Chicago (LCH) CRS

    Chicago, Illinois, 60614-3393, United States

  • Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases

    Augusta, Georgia, 30912, United States

  • Metropolitan Hosp. NICHD CRS

    New York, New York, 10029, United States

  • Miller Children's Hosp. Long Beach CA NICHD CRS

    Long Beach, California, 90806, United States

  • Molepolole CRS

    Gaborone, Botswana

  • Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program

    Chicago, Illinois, 60608, United States

  • Nyu Ny Nichd Crs

    New York, New York, 10016, United States

  • Pediatric Perinatal HIV Clinical Trials Unit CRS

    Miami, Florida, 33136, United States

  • Phayao Provincial Hosp. CRS

    T.Tom, Muang, Changwat Phayao, 56000, Thailand

  • Philadelphia IMPAACT Unit CRS

    Philadelphia, Pennsylvania, 19104, United States

  • Prapokklao Hosp. CRS

    Chanthaburi, 22000, Thailand

  • Regional Med. Ctr. at Memphis

    Memphis, Tennessee, 38103, United States

  • Rush Univ. Cook County Hosp. Chicago NICHD CRS

    Chicago, Illinois, 60612, United States

  • Rutgers - New Jersey Medical School CRS

    Newark, New Jersey, 07103, United States

  • SOM Federal University Minas Gerais Brazil NICHD CRS

    Belo Horizonte, Minas Gerais, 30.130-100, Brazil

  • SUNY Stony Brook NICHD CRS

    Stony Brook, New York, 11794, United States

  • San Juan City Hosp. PR NICHD CRS

    San Juan, 00936, Puerto Rico

  • Seattle Children's Research Institute CRS

    Seattle, Washington, 98101, United States

  • Siriraj Hospital ,Mahidol University NICHD CRS

    Bangkok, Bangkoknoi, 10700, Thailand

  • St. Jude Children's Research Hospital CRS

    Memphis, Tennessee, 38105-3678, United States

  • Tulane Univ. New Orleans NICHD CRS

    New Orleans, Louisiana, 70112, United States

  • UAB Pediatric Infectious Diseases CRS

    Birmingham, Alabama, 35233, United States

  • USF - Tampa NICHD CRS

    Tampa, Florida, 33606, United States

  • Univ. of California San Francisco NICHD CRS

    San Francisco, California, 94143, United States

  • Univ. of Colorado Denver NICHD CRS

    Aurora, Colorado, 80045, United States

  • Univ. of Florida Jacksonville NICHD CRS

    Jacksonville, Florida, 32209, United States

  • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.

    Chicago, Illinois, 60612, United States

  • Univ. of Maryland Baltimore NICHD CRS

    Baltimore, Maryland, 21201, United States

  • Univ. of Sao Paulo Brazil NICHD CRS

    São Paulo, 14049-900, Brazil

  • University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program

    La Jolla, California, 92093-0672, United States

  • Usc La Nichd Crs

    Los Angeles, California, 90089, United States

  • WNE Maternal Pediatric Adolescent AIDS CRS

    Worcester, Massachusetts, 01605, United States

  • Washington Hosp. Ctr. NICHD CRS

    Washington D.C., District of Columbia, 20010, United States

  • Wits RHI Shandukani Research Centre CRS

    Johannesburg, Gauteng, 2001, South Africa

  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.