HIV InfectionsPhase 2NCT00006075
A Study of Chlorhexidine in the Prevention of HIV-1 Transmission From Mothers to Their Babies
A Phase 2 study testing Chlorhexidine gluconate in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to find the best strength of chlorhexidine (a solution that kills germs), for washing the mother's vagina during labor and the newborn baby, that may reduce the chance of HIV being passed from an HIV-positive mother to the baby. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Chlorhexidine gluconate
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Aug 2007
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers may be eligible for this study if they:
- Receive HIV testing and counseling (both HIV-positive and HIV-negative women will be enrolled).
- Are at least 36 weeks pregnant.
- Are receiving routine prenatal care at the Chris Hani Baragwanath Hospital maternity unit in Soweto, South Africa.
Who cannot join
- Mothers will not be eligible if they:
- Have severe complications during the pregnancy, such as bleeding before birth.
- Have a C-section by choice.
- Have obvious genital sores at the time of labor.
- Have a baby that is positioned a certain way during delivery.
- Receive prostaglandin tablets, in the vagina, during labor.
- Have major medical conditions, such as TB or diabetes (except HIV, in HIV-positive women).
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann Koonce
Research Triangle Park, North Carolina, 27709
About this study
Official title: Phase IIA Study of Tolerance and Safety of Differing Concentrations of Chlorhexidine, for Peripartum Vaginal and Infant Washes, to Prevent Mother to Infant HIV-1 Transmission
The purpose of this study is to find the best strength of chlorhexidine (a solution that kills germs), for washing the mother's vagina during labor and the newborn baby, that may reduce the chance of HIV being passed from an HIV-positive mother to the baby.
When used as a wash on the vagina during labor, and on a newborn shortly after birth, a higher dose of chlorhexidine is more likely to reduce the rate of HIV-1 transmission from mother to baby. Laboratory tests suggest that a higher dose of chlorhexidine will be more effective in killing HIV.
Read the detailed description
The principal hypothesis of this protocol is that, in the context of routine oral/nasal suctioning of infants, a higher concentration of chlorhexidine for peripartum vaginal and postpartum newborn cleansing results in reduction in maternal child transmission (MCT) of HIV. The in vitro data suggest that a higher concentration of chlorhexidine in the primary wash solution is much more likely to have a virucidal effect perinatally and thus reduce MCT.
Perinatal intervention consists of the following: 1) cervicovaginal wash of the entire birth canal with a chlorhexidine solution at the time of each vaginal examination of a mother in labor; 2) immediate suctioning of the nasal and oral passages of the infant at the time the head emerges (fluids to be tested for viral load at future date); and 3) thorough washing of the baby with a chlorhexidine solution immediately after delivery. Blood samples are collected from some infants for measurement of chlorhexidine levels approximately 2 hours post-washing. During the 24 to 48 hours following delivery, infants are examined and mothers are queried using standardized questionnaires for subjective complaints related to the chlorhexidine washes. Speculum-aided vaginal exams are done for any persistent (greater than 24 hours) or severe complaints.
- Conditions
- HIV Infections
- Being tested
- Chlorhexidine gluconate
- Keywords
- Pregnancy Complications, Infectious, Dose-Response Relationship, Drug, Polymerase Chain Reaction, Disease Transmission, Vertical, Labor, Disinfectants, Vagina, Chlorhexidine, Irrigation
- 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.
Chlorhexidine gluconateDrug
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 completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Prevention
- Enrolment
- 150 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Craig Wilson, Study chairSten Vermund, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006075
- Sponsor's protocol ID
- HIVNET 025
- Status last verified
- Jun 2004
- First submitted
- 27 Jul 2000
- Last updated
- 30 Sep 2008
- Results posted
- No
Publications
Wilson CM, Gray G, Read JS, Mwatha A, Lala S, Johnson S, Violari A, Sibiya PM, Fleming TR, Koonce A, Vermund SH, McIntyre J. Tolerance and safety of different concentrations of chlorhexidine for peripartum vaginal and infant washes: HIVNET 025. J Acquir Immune Defic Syndr. 2004 Feb 1;35(2):138-43. doi: 10.1097/00126334-200402010-00006.
PubMed 14722445
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIA Study of Tolerance and Safety of Differing Concentrations of Chlorhexidine, for Peripartum Vaginal and Infant Washes, to Prevent Mother to Infant HIV-1 Transmission
- ClinicalTrials.gov ID
- NCT00006075
- Acronym / sponsor ID
- HIVNET 025
- Conditions
- HIV Infections
- Keywords
- Pregnancy Complications, Infectious, Dose-Response Relationship, Drug, Polymerase Chain Reaction, Disease Transmission, Vertical, Labor, Disinfectants, Vagina, Chlorhexidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Aug 2007 (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 find the best strength of chlorhexidine (a solution that kills germs), for washing the mother's vagina during labor and the newborn baby, that may reduce the chance of HIV being passed from an HIV-positive mother to the baby.
When used as a wash on the vagina during labor, and on a newborn shortly after birth, a higher dose of chlorhexidine is more likely to reduce the rate of HIV-1 transmission from mother to baby. Laboratory tests suggest that a higher dose of chlorhexidine will be more effective in killing HIV.
Detailed description
The principal hypothesis of this protocol is that, in the context of routine oral/nasal suctioning of infants, a higher concentration of chlorhexidine for peripartum vaginal and postpartum newborn cleansing results in reduction in maternal child transmission (MCT) of HIV. The in vitro data suggest that a higher concentration of chlorhexidine in the primary wash solution is much more likely to have a virucidal effect perinatally and thus reduce MCT.
Perinatal intervention consists of the following: 1) cervicovaginal wash of the entire birth canal with a chlorhexidine solution at the time of each vaginal examination of a mother in labor; 2) immediate suctioning of the nasal and oral passages of the infant at the time the head emerges (fluids to be tested for viral load at future date); and 3) thorough washing of the baby with a chlorhexidine solution immediately after delivery. Blood samples are collected from some infants for measurement of chlorhexidine levels approximately 2 hours post-washing. During the 24 to 48 hours following delivery, infants are examined and mothers are queried using standardized questionnaires for subjective complaints related to the chlorhexidine washes. Speculum-aided vaginal exams are done for any persistent (greater than 24 hours) or severe complaints.
Study design
- Primary purpose
- Prevention
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Receive HIV testing and counseling (both HIV-positive and HIV-negative women will be enrolled).
- Are at least 36 weeks pregnant.
- Are receiving routine prenatal care at the Chris Hani Baragwanath Hospital maternity unit in Soweto, South Africa.
Key exclusion criteria (7 listed)
- Have severe complications during the pregnancy, such as bleeding before birth.
- Have a C-section by choice.
- Have obvious genital sores at the time of labor.
- Have a baby that is positioned a certain way during delivery.
- Receive prostaglandin tablets, in the vagina, during labor.
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 |
|---|---|---|
| Chlorhexidine gluconate | 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 30 Sep 2008.
- Background: PubMed 14722445Wilson CM, Gray G, Read JS, Mwatha A, Lala S, Johnson S, Violari A, Sibiya PM, Fleming TR, Koonce A, Vermund SH, McIntyre J. Tolerance and safety of different concentrations of chlorhexidine for peripartum vaginal and infant washes: HIVNET 025. J Acquir Immune Defic Syndr. 2004 Feb 1;35(2):138-43. doi: 10.1097/00126334-200402010-00006.
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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.
Craig Wilson study chair
Sten Vermund study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chlorhexidine gluconate in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 7 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 30 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NCT00006075, which also lists 1 linked publication.
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 30 Sep 2008.