HIV InfectionsPhase 1NCT00000808
A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
A Phase 1 study testing Nevirapine in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites in 2 countries.
Trial summary
To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to the mother during active labor, and when their neonates are dosed during the first week of life. Read more about this study
- Who is it for?
- Ages 13 to 60 years, women only
- Conditions the study is for
- HIV Infections, Pregnancy
- What is being tested?
- Nevirapine
- How many people
- 49 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Start not givento Sep 1998
- 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 13 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- AZT (mothers and neonates).
- Oral asthma inhalers (mothers).
- Concurrent Treatment:
- Allowed:
Show all 13Show fewer
- Phototherapy (neonates).
- MOTHERS must have:
- HIV infection.
- Estimated gestational age >= 34 weeks.
- No active opportunistic infection at study entry.
- PER AMENDMENT 8/27/96:
- A pre-enrollment plasma HIV-1 RNA level greater than 10,000 copies/ml.
Who cannot join
- Co-existing Condition:
- MOTHERS with the following symptoms or conditions are excluded:
- Intrauterine growth retardation.
- Fetal anomaly incompatible with life as determined by pre-entry ultrasound.
- Participation during current pregnancy in any other therapeutic or vaccine perinatal trial.
- Known hypersensitivity to any benzodiazepine.
Show all 22Show fewer
- Serious bacterial infection.
- Concurrent Medication:
- Excluded:
- Any antiretroviral other than AZT.
- Corticosteroids (other than oral asthma inhalers).
- Anticoagulants.
- Any clavulanic acid-containing formulation (e.g., Augmentin, Timentin).
- Benzodiazepines other than study drug.
- Phenobarbital.
- Barbiturates.
- Antacids.
- Magnesium sulfate.
- Prior Medication:
- Excluded:
- Prior nevirapine.
- Current use of illicit substances and/or active chronic alcohol use.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States15 sites
Children's Hosp of Boston
Boston, Massachusetts, 021155724
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
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
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
Mount Sinai Med Ctr / Pediatrics
New York, New York, 10029
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
San Francisco Gen Hosp
San Francisco, California, 94110
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
About this study
To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to the mother during active labor, and when their neonates are dosed during the first week of life. To determine the short-term safety profile of mothers receiving zidovudine (AZT) who received nevirapine during active labor, and their neonates who received no dose, a single dose, or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of life.
Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.
Read the detailed description
Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.
Pregnant women in active labor receive single doses of oral nevirapine. The neonates of the first 4-6 (PER AMENDMENT 8/27/96, was 4) mothers receive no drug, while the neonates of the second 4-6 (PER AMENDMENT 8/27/96, was 4) patient cohort receive a single dose of nevirapine. If neonatal antiviral levels of nevirapine are not sustained for 7 days after the single dose, a third cohort of 4-6 (PER AMENDMENT 8/27/96, was 4) pregnant women will receive a single dose of nevirapine and their neonates will receive multiple doses of nevirapine to maintain an antiviral effect for 7 days.
- Conditions
- HIV Infections, Pregnancy
- Being tested
- Nevirapine
- Keywords
- Pregnancy, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Nevirapine
- Medical subject headings
- HIV Infections, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
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 completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 1
- Primary purpose
- Treatment
- Enrolment
- 49 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sullivan JL, Study chairSperling R, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000808
- Sponsor's protocol ID
- ACTG 250
- Other IDs
- 11227
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Vazquez E. Two bucks a baby. Posit Aware. 1997 Mar-Apr;8(2):15.
PubMed 11364450Benson M, Shannon M. Nevirapine: ethical dilemmas and care for HIV-infected mothers. Focus. 1995 Jun;10(7):5-6.
PubMed 11362587McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
Mirochnick M, Sullivan J, Cort S, Mcnamara J, Fenton T, Sperling R. Safety and pharmacokinetics (pk) of nevirapine (NVP) in HIV-I infected pregnant women and their newborns. ACTG Protocol 250 Team. American Pediatric Association and Society for Pediatric Research annual meeting; 1996 May 6-10; Washington, D.C. Pediatr AIDS HIV Infect. 1996 Aug;7(4):280 (unnumbered abstract)
Mirochnick M, Fenton T, Gagnier P, Pav J, Gwynne M, Siminski S, Sperling RS, Beckerman K, Jimenez E, Yogev R, Spector SA, Sullivan JL. Pharmacokinetics of nevirapine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Pediatric AIDS Clinical Trials Group Protocol 250 Team. J Infect Dis. 1998 Aug;178(2):368-74. doi: 10.1086/515641.
PubMed 9697716
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
- ClinicalTrials.gov ID
- NCT00000808
- Acronym / sponsor ID
- ACTG 250
- Conditions
- HIV Infections, Pregnancy
- Keywords
- Pregnancy, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Nevirapine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Sep 1998 (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.
To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to the mother during active labor, and when their neonates are dosed during the first week of life. To determine the short-term safety profile of mothers receiving zidovudine (AZT) who received nevirapine during active labor, and their neonates who received no dose, a single dose, or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of life.
Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.
Detailed description
Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.
Pregnant women in active labor receive single doses of oral nevirapine. The neonates of the first 4-6 (PER AMENDMENT 8/27/96, was 4) mothers receive no drug, while the neonates of the second 4-6 (PER AMENDMENT 8/27/96, was 4) patient cohort receive a single dose of nevirapine. If neonatal antiviral levels of nevirapine are not sustained for 7 days after the single dose, a third cohort of 4-6 (PER AMENDMENT 8/27/96, was 4) pregnant women will receive a single dose of nevirapine and their neonates will receive multiple doses of nevirapine to maintain an antiviral effect for 7 days.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- AZT (mothers and neonates).
- Oral asthma inhalers (mothers).
- Phototherapy (neonates).
- HIV infection.
- Estimated gestational age >= 34 weeks.
Key exclusion criteria (22 listed)
- Intrauterine growth retardation.
- Fetal anomaly incompatible with life as determined by pre-entry ultrasound.
- Participation during current pregnancy in any other therapeutic or vaccine perinatal trial.
- Known hypersensitivity to any benzodiazepine.
- Serious bacterial infection.
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 4 Nov 2021.
- Background: PubMed 11364450Vazquez E. Two bucks a baby. Posit Aware. 1997 Mar-Apr;8(2):15.
- Background: PubMed 11362587Benson M, Shannon M. Nevirapine: ethical dilemmas and care for HIV-infected mothers. Focus. 1995 Jun;10(7):5-6.
- BackgroundMcKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
- BackgroundMirochnick M, Sullivan J, Cort S, Mcnamara J, Fenton T, Sperling R. Safety and pharmacokinetics (pk) of nevirapine (NVP) in HIV-I infected pregnant women and their newborns. ACTG Protocol 250 Team. American Pediatric Association and Society for Pediatric Research annual meeting; 1996 May 6-10; Washington, D.C. Pediatr AIDS HIV Infect. 1996 Aug;7(4):280 (unnumbered abstract)
- Background: PubMed 9697716Mirochnick M, Fenton T, Gagnier P, Pav J, Gwynne M, Siminski S, Sperling RS, Beckerman K, Jimenez E, Yogev R, Spector SA, Sullivan JL. Pharmacokinetics of nevirapine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Pediatric AIDS Clinical Trials Group Protocol 250 Team. J Infect Dis. 1998 Aug;178(2):368-74. doi: 10.1086/515641.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Sullivan JL study chair
Sperling R study chair
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nevirapine in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 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 13 inclusion and 22 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 4 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 16 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 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?
On the ClinicalTrials.gov record for NCT00000808, 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 4 Nov 2021.