HIV InfectionsPhase 2KiBSNCT00146380
A Study of Zidovudine/Lamivudine and Either Nevirapine or Nelfinavir for Reduction of Mother-to-child HIV Transmission During Breastfeeding
A Phase 2 study testing Zidovudine/Lamivudine and either Nevirapine or Nelfinavir and Breastfeeding for 6 months postpartum in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Kenya.
Trial summary
The purpose of the study is to demonstrate that a regimen using highly active antiretroviral therapy (HAART) to maximally suppress maternal viral load in the late antenatal period and during the first six months of lactation is safe, effective and can be implemented in resource poor settings in order to reduce the… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Zidovudine/Lamivudine and either Nevirapine or Nelfinavir and Breastfeeding for 6 months postpartum
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 520 participants
- Where
- 1 siteKenya
- Study dates
- Jul 2003to Jan 2013
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be a pregnant HIV-infected female presenting prior to 34 weeks gestation who has already chosen to breastfeed after receiving counseling on infant feeding choices according to UNAIDS guidelines which includes counseling and education about the overall benefits of breast feeding as well as the risks of HIV transmission to the infant inherent in breastfeeding.
- Report that they plan to reside in Kisumu for the next 2 years
- Be able to give competent, informed consent if >18 or have a parent or guardian who can do the same in the case of a minor.
- Be willing to comply with study requirements if they meet study eligibility criteria.
- Meet the following laboratory criteria at enrollment (Efforts will be made to address potentially correctable abnormalities such as anemia, prior to enrollment)
- Documentation of HIV-1 infection according to the Kenyan National PMCT testing algorithm.
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- Serum creatinine <1.5 mg/dl
- Hgb >7.0 g/dL
- Absolute neutrophil count > 1000 cells/ml
- Platelet count >50,000/ml
- SGPT < 2.5 times upper limit of normal
- Documentation of CD4 count results prior to beginning study drug; which will be used to determine the appropriate HAART regimen -i.e ZDV/3TC/NVP or ZDV/3TC/NLF
- Documentation of Hepatitis B and C infection status (Hepatitis B surface antigen and Hepatitis C antibody)
- Have signed consent and met clinical and laboratory eligibility criteria in order to be enrolled in the trial by 34-36 weeks gestation (preferably at 34 weeks).
Who cannot join
- Is participating in other HIV vaccine or antiretroviral trials.
- Has substantial hypersensitivity to any benzodiazepine, including Nevirapine.
- Has history of prior substantial intolerance or severe allergic reaction to Nevirapine, Zidovudine, Lamivudine or Nelfinavir.
- For women who will be placed on NVP, ongoing treatment with rifampin, anticoagulants, benzodiazepines, and magnesium sulfate at time of planned enrollment. For those women who will be placed on NLF, ongoing treatment with amiodarone, quinidine, ergot derivative drugs, rifampin, pimozide, St John's work, lovastatin, simvastatin, midazolam or triazolam
- Has evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, or allergic disease that would compromise the ability of the participant to complete the study or the study requirements as determined by the principal investigator or designated associate. The clinical significance of any abnormality is to be evaluated in the context of the safety of the patient volunteer and the objectives of this study.
- Has a history of cytotoxic chemotherapy within one month prior to study entry or current diagnosis of malignancy for which systemic therapy is expected to be required during the period of study.
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- Blood pressure > 160 mm Hg systolic or > 110 mm Hg diastolic.
- Chronic alcohol or illicit drug use.
- Women who become pregnant again during the study follow-up will NOT be eligible for re-enrollment in the trial if they were enrolled for their previous pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Open Label Clinical Trial of Maternal Zidovudine/Lamivudine and Either Nevirapine or Nelfinavir for Maximal Reduction of Mother-to-child HIV Transmission in Resource-limited Settings Among Breastfeeding Populations
The purpose of the study is to demonstrate that a regimen using highly active antiretroviral therapy (HAART) to maximally suppress maternal viral load in the late antenatal period and during the first six months of lactation is safe, effective and can be implemented in resource poor settings in order to reduce the risk of HIV transmission to the infant.
Read the detailed description
Background: Approximately 800,000 HIV-infected infants are born each year, two thirds of them in sub-Saharan Africa. The rate of HIV transmission from mother to infant is estimated at 13-48% in the absence of antiretroviral treatment. Interventions currently available to prevent mother to child transmission in resource-limited settings among breastfeeding populations child HIV transmission during the breastfeeding period. Because safe alternatives to breastfeeding are not currently a viable option for many HIV-infected women in sub-Saharan Africa, it is important to identify interventions to decrease transmission to the infant during this period.
Objective: To demonstrate that a regimen using highly active antiretroviral therapy (HAART) to maximally suppress maternal viral load in the late antenatal period and during the first six months of lactation is safe, effective and can be implemented in resource poor settings in order to reduce the risk of HIV transmission to the infant.
Study Design: The study will be an open label Phase II trial of Zidovudine/Lamivudine and depending on maternal CD4 count, either Nevirapine or Nelfinavir to assess the safety, tolerance and activity of maternal HAART to reduce the risk of transmission among breastfeeding HIV infected women in Kisumu Kenya.
Justification: Transmission through breastfeeding accounts for 25-40% of all mother-to-child transmission of HIV. This trial will assess the safety and activity of a potent triple drug combination to lower maternal viral loadprenatally, intrapartum and during breast feeding. The regimen will be given to HIV infected women from 34 weeks gestation through 6 months of breastfeeding postpartum. Infants will receive a single dose of NVP. Women will be encouraged to breastfeed exclusively and wean abruptly at 6 months. Mother and infant will be followed for 24 months. Clinical and laboratory evaluations will be performed periodically to determine infection status of the infant and side effects of medications to mother and infant. The estimated sample size needed to address both transmission reduction of HAART in comparison to single dose NVP as well as related safety of the two HAART regimens is 520 mother-infant pairs. Comparison will be made with data from previous studies (HIVNET O12 in Uganda and the malaria vertical transmission study in Kisumu) and with data from current Prevention of Mother to Child Transmission (PMCT) programs in Kisumu.
Expectations and significance: A HAART regimen of this nature may potentially show a dramatic decrease in transmission when compared to existing PMCT regimens. Given the continued decreasing costs of ARVs and the relatively low efficacy of existing PMCT regimens, such a regimen would be seriously considered for wide implementation in resource poor settings and elsewhere.
- Conditions
- HIV Infections
- Being tested
- Zidovudine/Lamivudine and either Nevirapine or Nelfinavir, Breastfeeding for 6 months postpartum
- Keywords
- Prevention Mother-to-Child HIV transmission, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zidovudine/Lamivudine and either Nevirapine or NelfinavirDrug
Zidovudine 300mg po bid from 34 weeks gestation to 6 months postpartum Lamivudine 150mg po bid from 34 weeks gestation to 6 months postpartum AND EITHER Nevirapine 200mg po qd for 2 weeks as lead in then bid from 34 weeks gestation to 6 months postpartum OR Nelfinavir 1250mg po bid from 34 weeks gestation to 6 months postpartum
ARVs continued for those that meet WHO treatment criteria
Breastfeeding for 6 months postpartumBehavioural
Exclusive breastfeeding till five and one half months with rapid weaning over 2 weeks and cessation of breastfeeding at 6 months when ARVs are discontinued
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To estimate the cumulative risk of infant infection at 6 weeks, 9 months, and 18 months of age among breast fed infants. The anticipated outcome is a transmission rate of <6% at 6 weeks and <8% at 18 months of age.
Measured: 6 weeks, 9 months, 18 months
Secondary outcomes (2)
1. To determine infant HIV-free survival rates at 24 months of age.
Measured: 24 months
2. To evaluate infant and maternal safety, and tolerance of ZDV/3TC and Nevirapine or Nelfinavir given to HIV-infected pregnant women from 34 weeks gestation to 6 months postpartum
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionJan 2009
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Timothy K Thomas, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146380
- Sponsor's protocol ID
- CDC-NCHSTP-3677
- Other IDs
- UR6/CCU018970
- Acronym
- KiBS
- Status last verified
- Apr 2025
- First submitted
- 2 Sep 2005
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zeh C, Weidle PJ, Nafisa L, Lwamba HM, Okonji J, Anyango E, Bondo P, Masaba R, Fowler MG, Nkengasong JN, Thigpen MC, Thomas T. HIV-1 drug resistance emergence among breastfeeding infants born to HIV-infected mothers during a single-arm trial of triple-antiretroviral prophylaxis for prevention of mother-to-child transmission: a secondary analysis. PLoS Med. 2011 Mar;8(3):e1000430. doi: 10.1371/journal.pmed.1000430. Epub 2011 Mar 29.
PubMed 21468304Thomas TK, Masaba R, Borkowf CB, Ndivo R, Zeh C, Misore A, Otieno J, Jamieson D, Thigpen MC, Bulterys M, Slutsker L, De Cock KM, Amornkul PN, Greenberg AE, Fowler MG; KiBS Study Team. Triple-antiretroviral prophylaxis to prevent mother-to-child HIV transmission through breastfeeding--the Kisumu Breastfeeding Study, Kenya: a clinical trial. PLoS Med. 2011 Mar;8(3):e1001015. doi: 10.1371/journal.pmed.1001015. Epub 2011 Mar 29.
PubMed 21468300Harris JR, Greene SK, Thomas TK, Ndivo R, Okanda J, Masaba R, Nyangau I, Thigpen MC, Hoekstra RM, Quick RE. Effect of a point-of-use water treatment and safe water storage intervention on diarrhea in infants of HIV-infected mothers. J Infect Dis. 2009 Oct 15;200(8):1186-93. doi: 10.1086/605841.
PubMed 19758095
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label Clinical Trial of Maternal Zidovudine/Lamivudine and Either Nevirapine or Nelfinavir for Maximal Reduction of Mother-to-child HIV Transmission in Resource-limited Settings Among Breastfeeding Populations
- ClinicalTrials.gov ID
- NCT00146380
- Acronym / sponsor ID
- KiBS / CDC-NCHSTP-3677
- Conditions
- HIV Infections
- Keywords
- Prevention Mother-to-Child HIV transmission, HIV Seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Jul 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Sep 2005 (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 the study is to demonstrate that a regimen using highly active antiretroviral therapy (HAART) to maximally suppress maternal viral load in the late antenatal period and during the first six months of lactation is safe, effective and can be implemented in resource poor settings in order to reduce the risk of HIV transmission to the infant.
Detailed description
Background: Approximately 800,000 HIV-infected infants are born each year, two thirds of them in sub-Saharan Africa. The rate of HIV transmission from mother to infant is estimated at 13-48% in the absence of antiretroviral treatment. Interventions currently available to prevent mother to child transmission in resource-limited settings among breastfeeding populations child HIV transmission during the breastfeeding period. Because safe alternatives to breastfeeding are not currently a viable option for many HIV-infected women in sub-Saharan Africa, it is important to identify interventions to decrease transmission to the infant during this period.
Objective: To demonstrate that a regimen using highly active antiretroviral therapy (HAART) to maximally suppress maternal viral load in the late antenatal period and during the first six months of lactation is safe, effective and can be implemented in resource poor settings in order to reduce the risk of HIV transmission to the infant.
Study Design: The study will be an open label Phase II trial of Zidovudine/Lamivudine and depending on maternal CD4 count, either Nevirapine or Nelfinavir to assess the safety, tolerance and activity of maternal HAART to reduce the risk of transmission among breastfeeding HIV infected women in Kisumu Kenya.
Justification: Transmission through breastfeeding accounts for 25-40% of all mother-to-child transmission of HIV. This trial will assess the safety and activity of a potent triple drug combination to lower maternal viral loadprenatally, intrapartum and during breast feeding. The regimen will be given to HIV infected women from 34 weeks gestation through 6 months of breastfeeding postpartum. Infants will receive a single dose of NVP. Women will be encouraged to breastfeed exclusively and wean abruptly at 6 months. Mother and infant will be followed for 24 months. Clinical and laboratory evaluations will be performed periodically to determine infection status of the infant and side effects of medications to mother and infant. The estimated sample size needed to address both transmission reduction of HAART in comparison to single dose NVP as well as related safety of the two HAART regimens is 520 mother-infant pairs. Comparison will be made with data from previous studies (HIVNET O12 in Uganda and the malaria vertical transmission study in Kisumu) and with data from current Prevention of Mother to Child Transmission (PMCT) programs in Kisumu.
Expectations and significance: A HAART regimen of this nature may potentially show a dramatic decrease in transmission when compared to existing PMCT regimens. Given the continued decreasing costs of ARVs and the relatively low efficacy of existing PMCT regimens, such a regimen would be seriously considered for wide implementation in resource poor settings and elsewhere.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Be a pregnant HIV-infected female presenting prior to 34 weeks gestation who has already chosen to breastfeed after receiving counseling on infant feeding choices according to UNAIDS guidelines which includes counseling and education about the overall benefits of breast feeding as well as the risks of HIV transmission to the infant inherent in breastfeeding.
- Report that they plan to reside in Kisumu for the next 2 years
- Be able to give competent, informed consent if >18 or have a parent or guardian who can do the same in the case of a minor.
- Be willing to comply with study requirements if they meet study eligibility criteria.
- Meet the following laboratory criteria at enrollment (Efforts will be made to address potentially correctable abnormalities such as anemia, prior to enrollment)
Key exclusion criteria (9 listed)
- Is participating in other HIV vaccine or antiretroviral trials.
- Has substantial hypersensitivity to any benzodiazepine, including Nevirapine.
- Has history of prior substantial intolerance or severe allergic reaction to Nevirapine, Zidovudine, Lamivudine or Nelfinavir.
- For women who will be placed on NVP, ongoing treatment with rifampin, anticoagulants, benzodiazepines, and magnesium sulfate at time of planned enrollment. For those women who will be placed on NLF, ongoing treatment with amiodarone, quinidine, ergot derivative drugs, rifampin, pimozide, St John's work, lovastatin, simvastatin, midazolam or triazolam
- Has evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, or allergic disease that would compromise the ability of the participant to complete the study or the study requirements as determined by the principal investigator or designated associate. The clinical significance of any abnormality is to be evaluated in the context of the safety of the patient volunteer and the objectives of this study.
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 |
|---|---|---|
| Zidovudine/Lamivudine and either Nevirapine or NelfinavirZidovudine 300mg po bid from 34 weeks gestation to 6 months postpartum Lamivudine 150mg po bid from 34 weeks gestation to 6 months postpartum AND EITHER Nevirapine 200mg po qd for 2 weeks as lead in then bid from 34 weeks gestation to 6 months postpartum OR Nelfinavir 1250mg po bid from 34 weeks gestation to 6 months postpartum ARVs continued for those that meet WHO treatment criteria | Drug | – |
| Breastfeeding for 6 months postpartumExclusive breastfeeding till five and one half months with rapid weaning over 2 weeks and cessation of breastfeeding at 6 months when ARVs are discontinued | Behavioural | – |
Primary outcome
1. To estimate the cumulative risk of infant infection at 6 weeks, 9 months, and 18 months of age among breast fed infants. The anticipated outcome is a transmission rate of <6% at 6 weeks and <8% at 18 months of age.
Time frame: 6 weeks, 9 months, 18 months
2 secondary outcomes
1. To determine infant HIV-free survival rates at 24 months of age.
Time frame: 24 months
2. To evaluate infant and maternal safety, and tolerance of ZDV/3TC and Nevirapine or Nelfinavir given to HIV-infected pregnant women from 34 weeks gestation to 6 months postpartum
Time frame: 12 months
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 15 Apr 2025.
- Derived from this study: PubMed 21468304Zeh C, Weidle PJ, Nafisa L, Lwamba HM, Okonji J, Anyango E, Bondo P, Masaba R, Fowler MG, Nkengasong JN, Thigpen MC, Thomas T. HIV-1 drug resistance emergence among breastfeeding infants born to HIV-infected mothers during a single-arm trial of triple-antiretroviral prophylaxis for prevention of mother-to-child transmission: a secondary analysis. PLoS Med. 2011 Mar;8(3):e1000430. doi: 10.1371/journal.pmed.1000430. Epub 2011 Mar 29.
- Derived from this study: PubMed 21468300Thomas TK, Masaba R, Borkowf CB, Ndivo R, Zeh C, Misore A, Otieno J, Jamieson D, Thigpen MC, Bulterys M, Slutsker L, De Cock KM, Amornkul PN, Greenberg AE, Fowler MG; KiBS Study Team. Triple-antiretroviral prophylaxis to prevent mother-to-child HIV transmission through breastfeeding--the Kisumu Breastfeeding Study, Kenya: a clinical trial. PLoS Med. 2011 Mar;8(3):e1001015. doi: 10.1371/journal.pmed.1001015. Epub 2011 Mar 29.
- Derived from this study: PubMed 19758095Harris JR, Greene SK, Thomas TK, Ndivo R, Okanda J, Masaba R, Nyangau I, Thigpen MC, Hoekstra RM, Quick RE. Effect of a point-of-use water treatment and safe water storage intervention on diarrhea in infants of HIV-infected mothers. J Infect Dis. 2009 Oct 15;200(8):1186-93. doi: 10.1086/605841.
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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.
Timothy K Thomas, MD principal investigator
Centers for Disease Control and Prevention
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 Zidovudine/Lamivudine and either Nevirapine or Nelfinavir and Breastfeeding for 6 months postpartum in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Kenya.
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 14 inclusion and 9 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 15 Apr 2025. 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 Kenya. 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.
What does the primary outcome measure?
1. To estimate the cumulative risk of infant infection at 6 weeks, 9 months, and 18 months of age among breast fed infants. The anticipated outcome is a transmission rate of <6% at 6 weeks and <8% at 18 months of age. (time frame: 6 weeks, 9 months, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00146380, which also lists 3 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 15 Apr 2025.