HIV InfectionsPhase 3NCT00001135
A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Infants
A Phase 3 study testing Nevirapine in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 sites in 2 countries.
Trial summary
The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their infants can help reduce the chance that a mother will give HIV to her baby during delivery. NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their infants. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Pregnancy
- What is being tested?
- Nevirapine
- How many people
- 2,009 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Start not givento May 2001
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are an HIV-positive pregnant woman.
- Have been pregnant for at least 28 weeks.
- Are at least 13 years of age (consent of parent or guardian is required if under 18).
Who cannot join
- You will not be eligible for this study if:
- You intend to breast-feed.
- You are allergic to benzodiazepines (a type of tranquilizer).
- You have a liver disorder.
- You have received nonnucleoside reverse transcriptase inhibitors (NNRTIs), a class of anti-HIV drugs.
- You refuse to take ZDV.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States19 sites
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
Children's Hosp of Boston
Boston, Massachusetts, 021155724
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
Duke Univ Med Ctr
Durham, North Carolina, 277103499
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
Univ of Miami (Pediatric)
Miami, Florida, 33161
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Columbia Presbyterian Med Ctr
New York, New York, 10032
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
Puerto Rico1 site
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067
About this study
Official title: A Phase III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women
The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their infants can help reduce the chance that a mother will give HIV to her baby during delivery.
NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their infants. NVP is inexpensive and is easily absorbed by the mother and transferred to the infant. It is thought that even a single dose to the mother and infant may provide enough protection to the baby during the time of exposure to HIV at birth.
Read the detailed description
NVP has several properties that make it an attractive candidate for antiretroviral therapy to interrupt HIV-1 transmission in the intrapartum and early postpartum period. The pharmacokinetic profile suggests that NVP would be rapidly absorbed by the mother and transferred to the infant in utero when given during labor and delivery. The HIV-1 antiviral activity is rapid with significant reduction in plasma virus occurring within a few days of drug administration. In addition, NVP has been shown to penetrate cell-free virions and inactivate virion-associated reverse transcriptase (RT) in situ. This property would be potentially useful in inactivating cell-free virions in the genital tract as well as in breast milk. These characteristics of NVP suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of NVP may provide a prophylactic level of NVP in the infant during the time of exposure to virus in the birth canal and/or in the maternal blood. In addition, NVP may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk.
Mothers are randomized to receive either a single oral dose of NVP during labor or the corresponding NVP placebo. Randomization occurs at any time after the 28th week of gestation. To assure balance between the treatment groups, the randomization is stratified using 2 factors: (1) antiretroviral therapy during the current pregnancy (no antiretroviral therapy at all, monotherapy [with no multi-agent therapy] for any duration, or multi-agent therapy for any duration), and (2) CD4 cell count at the time of randomization (less than 200 cells, 200 to 399 cells, or 400 cells or greater). Mothers are followed on-study for 4 to 6 weeks postpartum. All mothers are required to incorporate zidovudine (ZDV) into their current treatment regimen and should continue ZDV during delivery and give ZDV to their infants as recommended. ZDV will not be provided as part of the study.
Infants receive a single oral dose of NVP (or the corresponding placebo) administered between 48 and 72 hours of life. The infant's study drug is the same as the mother's randomized treatment assignment. Infants are dosed with study drug according to their randomization group regardless of whether the mother received study drug or not. Infants are followed for 6 months of life and are tested for HIV at birth, 4 to 6 weeks of life, 3 months of life, and 6 months of life.
- Conditions
- HIV Infections, Pregnancy
- Being tested
- Nevirapine
- Keywords
- Placebos, Pregnancy, Pregnancy Complications, Infectious, Nevirapine, Disease Transmission, Vertical, Labor, Anti-HIV Agents
- Medical subject headings
- HIV Infections, Pregnancy Complications, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
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 completionMay 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Masking
- Double blind
- Enrolment
- 2,009 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Dorenbaum A, Study chairSullivan JL, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001135
- Sponsor's protocol ID
- ACTG 316B
- Other IDs
- 11292
- Status last verified
- Oct 2021
- First submitted
- 23 Jan 2000
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Cunningham CK, Balasubramanian R, Delke I, Maupin R, Mofenson L, Dorenbaum A, Sullivan JL, Gonzalez-Garcia A, Thorpe E, Rathore M, Gelber RD. The impact of race/ethnicity on mother-to-child HIV transmission in the United States in Pediatric AIDS Clinical Trials Group Protocol 316. J Acquir Immune Defic Syndr. 2004 Jul 1;36(3):800-7. doi: 10.1097/00126334-200407010-00006.
PubMed 15213563Watts DH, Balasubramanian R, Maupin RT Jr, Delke I, Dorenbaum A, Fiore S, Newell ML, Delfraissy JF, Gelber RD, Mofenson LM, Culnane M, Cunningham CK; PACTG 316 Study Team. Maternal toxicity and pregnancy complications in human immunodeficiency virus-infected women receiving antiretroviral therapy: PACTG 316. Am J Obstet Gynecol. 2004 Feb;190(2):506-16. doi: 10.1016/j.ajog.2003.07.018.
PubMed 14981398
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 III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women
- ClinicalTrials.gov ID
- NCT00001135
- Acronym / sponsor ID
- ACTG 316B
- Conditions
- HIV Infections, Pregnancy
- Keywords
- Placebos, Pregnancy, Pregnancy Complications, Infectious, Nevirapine, Disease Transmission, Vertical, Labor, Anti-HIV Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,009 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 2001 (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.
The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their infants can help reduce the chance that a mother will give HIV to her baby during delivery.
NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their infants. NVP is inexpensive and is easily absorbed by the mother and transferred to the infant. It is thought that even a single dose to the mother and infant may provide enough protection to the baby during the time of exposure to HIV at birth.
Detailed description
NVP has several properties that make it an attractive candidate for antiretroviral therapy to interrupt HIV-1 transmission in the intrapartum and early postpartum period. The pharmacokinetic profile suggests that NVP would be rapidly absorbed by the mother and transferred to the infant in utero when given during labor and delivery. The HIV-1 antiviral activity is rapid with significant reduction in plasma virus occurring within a few days of drug administration. In addition, NVP has been shown to penetrate cell-free virions and inactivate virion-associated reverse transcriptase (RT) in situ. This property would be potentially useful in inactivating cell-free virions in the genital tract as well as in breast milk. These characteristics of NVP suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of NVP may provide a prophylactic level of NVP in the infant during the time of exposure to virus in the birth canal and/or in the maternal blood. In addition, NVP may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk.
Mothers are randomized to receive either a single oral dose of NVP during labor or the corresponding NVP placebo. Randomization occurs at any time after the 28th week of gestation. To assure balance between the treatment groups, the randomization is stratified using 2 factors: (1) antiretroviral therapy during the current pregnancy (no antiretroviral therapy at all, monotherapy [with no multi-agent therapy] for any duration, or multi-agent therapy for any duration), and (2) CD4 cell count at the time of randomization (less than 200 cells, 200 to 399 cells, or 400 cells or greater). Mothers are followed on-study for 4 to 6 weeks postpartum. All mothers are required to incorporate zidovudine (ZDV) into their current treatment regimen and should continue ZDV during delivery and give ZDV to their infants as recommended. ZDV will not be provided as part of the study.
Infants receive a single oral dose of NVP (or the corresponding placebo) administered between 48 and 72 hours of life. The infant's study drug is the same as the mother's randomized treatment assignment. Infants are dosed with study drug according to their randomization group regardless of whether the mother received study drug or not. Infants are followed for 6 months of life and are tested for HIV at birth, 4 to 6 weeks of life, 3 months of life, and 6 months of life.
Study design
- Primary purpose
- Prevention
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Are an HIV-positive pregnant woman.
- Have been pregnant for at least 28 weeks.
- Are at least 13 years of age (consent of parent or guardian is required if under 18).
Key exclusion criteria (6 listed)
- You intend to breast-feed.
- You are allergic to benzodiazepines (a type of tranquilizer).
- You have a liver disorder.
- You have received nonnucleoside reverse transcriptase inhibitors (NNRTIs), a class of anti-HIV drugs.
- You refuse to take ZDV.
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 |
|---|---|---|
| Nevirapine | 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.
- Background: PubMed 15213563Cunningham CK, Balasubramanian R, Delke I, Maupin R, Mofenson L, Dorenbaum A, Sullivan JL, Gonzalez-Garcia A, Thorpe E, Rathore M, Gelber RD. The impact of race/ethnicity on mother-to-child HIV transmission in the United States in Pediatric AIDS Clinical Trials Group Protocol 316. J Acquir Immune Defic Syndr. 2004 Jul 1;36(3):800-7. doi: 10.1097/00126334-200407010-00006.
- Background: PubMed 14981398Watts DH, Balasubramanian R, Maupin RT Jr, Delke I, Dorenbaum A, Fiore S, Newell ML, Delfraissy JF, Gelber RD, Mofenson LM, Culnane M, Cunningham CK; PACTG 316 Study Team. Maternal toxicity and pregnancy complications in human immunodeficiency virus-infected women receiving antiretroviral therapy: PACTG 316. Am J Obstet Gynecol. 2004 Feb;190(2):506-16. doi: 10.1016/j.ajog.2003.07.018.
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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.
Dorenbaum A study chair
Sullivan JL study chair
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nevirapine in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 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 4 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 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 20 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
On the ClinicalTrials.gov record for NCT00001135, which also lists 2 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 1 Nov 2021.