HIV InfectionsPhase 3NCT00074412
Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
A Phase 3 study testing Nevirapine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 4 countries.
Trial summary
The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice, especially in developing countries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,026 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Jan 2007to Nov 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 18 years of age or older
- HIV infected
- In third trimester of pregnancy, or at most 3 days post-delivery
- If baby is not yet born, planning to deliver at a facility where the study is being conducted
- Plan to breastfeed
- Born to an HIV infected mother who is eligible for the study
Show all 10Show fewer
- Weighed at least 2000 grams (4.4 lbs) at birth
- Blood sample obtained from the infant for HIV-1 DNA PCR, CBC with differential, and ALT
- Infants in a multiple birth are eligible only if both/all infants are eligible for the study and assigned to the same study group
- Able to breastfeed (e.g., mother and infant alive with no condition apparent that would prevent breastfeeding)
Who cannot join
- Complications with this pregnancy
- Serious medical condition that would interfere with the study (e.g., that would prevent breastfeeding or adherence to the follow-up schedule), as judged by the on-site clinician
- HIV DNA PCR positive at birth
- ALT of Grade 2 or higher at birth
- Hemoglobin, absolute neutrophil count, or platelet count of Grade 3 or higher at birth
- Skin rash of Grade 2B (urticaria), Grade 3, or above
- Confirmed or suspected clinical hepatitis
- Serious illness or condition that would interfere with compliance with study procedures
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Tanzania1 site
Muhimbili University of Health and Allied Sciences (MUHAS) CRS
Dar es Salaam
Uganda1 site
Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
Kampala, Mpigi
About this study
Official title: A Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV-Infected Women to Prevent Vertical HIV Transmission During Breastfeeding
The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice, especially in developing countries. The purpose of this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP) in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South Africa, Tanzania, Uganda, and Zimbabwe.
Read the detailed description
Breastfeeding provides general health, growth, and development benefits to an infant and significantly decreases the risk of certain acute and chronic diseases. Breastfeeding also decreases financial burden on the mother by decreasing the need for infant formula and health care for the infant. However, clinical evidence has shown that HIV can be readily transmitted through breast milk, although the risk of HIV MTCT over time while breastfeeding has been difficult to determine. Given the many advantages of breastfeeding and the significant obstacles to substituting formula for breast milk in developing countries, there is an urgent need to make breastfeeding by HIV infected women safe. This study will evaluate the safety and efficacy of an extended NVP regimen for prevention of MTCT of HIV through breastfeeding.
This study will last approximately 3.5 years. Mother/infant pairs will be enrolled over a period of 18 to 24 months. During the third trimester of pregnancy, HIV infected participants will receive HIV counseling and the intrapartum/neonatal two-dose NVP prophylaxis regimen to prevent MTCT. Mothers will also be given infant feeding options counseling and information on administering the study drug to the infant. Infants who were randomly assigned to receive a placebo and older than 6 weeks of age as of 08/10/07 OR to receive NVP will continue their treatment assignment. Infants who were randomly assigned to receive a placebo and are 6 weeks of age or less as of 08/10/07 will receive open-label NVP through Day 42 of life. For all other participants, all randomized infants will receive extended NVP through 6 weeks (Day 42) of life. All eligible infants will be randomly assigned to one of two groups at Week 6 following birth. The first group will receive extended NVP treatment; the second group will receive nevirapine placebo. Randomized infants will receive the extended NVP or NVP placebo through the first 6 months of life or until cessation of breastfeeding, whichever occurs earlier. Mothers will be instructed to begin giving their infants their assigned intervention starting at Day 3 to Day 7 postpartum. All mothers and infants outside of the study will be offered the local standard of care antiretroviral (ARV) regimen for the prevention of MTCT, but these ARVs will not be provided by the study.
Follow-up evaluations will be conducted at Weeks 2 and 6 and Months 3, 6, 12, and 18 for mothers, and at Weeks 2, 5, 6, and 8 and Months 3, 4, 5, 6, 9, 12, and 18 for infants. Study visits will include physical examinations, blood tests (including HIV tests), and medical histories. Study participants will be followed for up to 3.5 years.
- Conditions
- HIV Infections
- Being tested
- Nevirapine, Nevirapine placebo
- Keywords
- HIV Seronegativity, Treatment Experienced, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
Also called NVP
10 mg/ml oral suspension taken once daily up to 6 months of age. Dosage will increase throughout study.
Nevirapine placeboDrug
Also called NVP placebo
Oral suspension taken once daily up to 6 months of age
| Study group | Role | What they receive |
|---|---|---|
| 2A | Experimental | For infants: extended treatment with NVP Receives: Drug: Nevirapine |
| 2B | Placebo comparator | For infants: extended treatment with NVP placebo Receives: Drug: Nevirapine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study
Measured: At Month 6
Frequency and Severity of Adverse Reactions Among Participating Infants
For those infants who were randomized at 6 weeks and who initiated study drug we looked at the frequency and severity of adverse reactions through 18 months of study. The severity of all AEs was graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. The term severity is described as the intensity grade or level for specific event (i.e. mild, moderate, severe, or life-threatening). Severity is not the same as seriousness.
Measured: 6 weeks through 18 months
Secondary outcomes (3)
Proportion of Infants Who Are Alive and HIV-uninfected in the Two Arms
Measured: At Months 6 and 18
Relative Rates of HIV Infection in the Two Arms
Measured: At Month 18
Infant Survival Rates (Mortality Regardless of HIV Infection) in the Two Arms
Measured: At Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2003 (estimated)
- Study startJan 2007
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,026 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Hoosen M. Coovadia, MD, MBBS, Study chair, Centre for HIV Networking (HIVAN), Nelson Mandela School of Medicine, University of NatalLaura Guay, MD, Study chair, Johns Hopkins UniversityWafaie Fawzi, MD, PhD, Study chair, Department of Nutrition, Harvard School of Public HealthYvonne Maldonado, MD, Study chair, Stanford UniversityDaya Moodley, MSc, PhD, Study chair, Department of Obstetrics and Gynaecology, Nelson R Mandela School of Medicine, University of Natal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074412
- Sponsor's protocol ID
- HPTN 046
- Other IDs
- 10142
- Status last verified
- Jan 2023
- First submitted
- 11 Dec 2003
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Jackson JB, Musoke P, Fleming T, Guay LA, Bagenda D, Allen M, Nakabiito C, Sherman J, Bakaki P, Owor M, Ducar C, Deseyve M, Mwatha A, Emel L, Duefield C, Mirochnick M, Fowler MG, Mofenson L, Miotti P, Gigliotti M, Bray D, Mmiro F. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial. Lancet. 2003 Sep 13;362(9387):859-68. doi: 10.1016/S0140-6736(03)14341-3.
PubMed 13678973Mitchla Z, Sharland M. Current treatment options to prevent perinatal transmission of HIV. Expert Opin Pharmacother. 2000 Jan;1(2):239-48. doi: 10.1517/14656566.1.2.239.
PubMed 11249545Mofenson LM. Advances in the prevention of vertical transmission of human immunodeficiency virus. Semin Pediatr Infect Dis. 2003 Oct;14(4):295-308. doi: 10.1053/j.spid.2003.09.003.
PubMed 14724794Piwoz EG, Ross J, Humphrey J. Human immunodeficiency virus transmission during breastfeeding: knowledge, gaps, and challenges for the future. Adv Exp Med Biol. 2004;554:195-210.
PubMed 15384577Bhattacharya D, Guo R, Tseng CH, Emel L, Sun R, Zhang TH, Chiu SH, Stranix-Chibanda L, Chipato T, Ship H, Mohtashemi NZ, Kintu K, Manji KP, Moodley D, Maldonado Y, Currier JS, Thio CL. Hepatitis B virus clinical and virologic characteristics in an HIV perinatal transmission study in sub-Saharan Africa. AIDS. 2024 Mar 1;38(3):329-337. doi: 10.1097/QAD.0000000000003752. Epub 2023 Oct 17.
PubMed 37861675Bhattacharya D, Guo R, Tseng CH, Emel L, Sun R, Chiu SH, Stranix-Chibanda L, Chipato T, Mohtashemi NZ, Kintu K, Manji KP, Moodley D, Thio CL, Maldonado Y, Currier JS. Maternal HBV Viremia and Association With Adverse Infant Outcomes in Women Living With HIV and HBV. Pediatr Infect Dis J. 2021 Feb 1;40(2):e56-e61. doi: 10.1097/INF.0000000000002980.
PubMed 33181788Nandlal V, Moodley D, Grobler A, Bagratee J, Maharaj NR, Richardson P. Anaemia in pregnancy is associated with advanced HIV disease. PLoS One. 2014 Sep 15;9(9):e106103. doi: 10.1371/journal.pone.0106103. eCollection 2014.
PubMed 25222119Fowler MG, Coovadia H, Herron CM, Maldonado Y, Chipato T, Moodley D, Musoke P, Aizire J, Manji K, Stranix-Chibanda L, Fawzi W, Chetty V, Msweli L, Kisenge R, Brown E, Mwatha A, Eshleman SH, Richardson P, Allen M, George K, Andrew P, Zwerski S, Mofenson LM, Jackson JB; HPTN 046 Protocol Team. Efficacy and safety of an extended nevirapine regimen in infants of breastfeeding mothers with HIV-1 infection for prevention of HIV-1 transmission (HPTN 046): 18-month results of a randomized, double-blind, placebo-controlled trial. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):366-74. doi: 10.1097/QAI.0000000000000052.
PubMed 24189151Coovadia HM, Brown ER, Fowler MG, Chipato T, Moodley D, Manji K, Musoke P, Stranix-Chibanda L, Chetty V, Fawzi W, Nakabiito C, Msweli L, Kisenge R, Guay L, Mwatha A, Lynn DJ, Eshleman SH, Richardson P, George K, Andrew P, Mofenson LM, Zwerski S, Maldonado Y; HPTN 046 protocol team. Efficacy and safety of an extended nevirapine regimen in infant children of breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1 transmission (HPTN 046): a randomised, double-blind, placebo-controlled trial. Lancet. 2012 Jan 21;379(9812):221-8. doi: 10.1016/S0140-6736(11)61653-X. Epub 2011 Dec 22.
PubMed 22196945Aizire J, Fowler MG, Wang J, Shetty AK, Stranix-Chibanda L, Kamateeka M, Brown ER, Bolton SG, Musoke PM, Coovadia H. Extended prophylaxis with nevirapine and cotrimoxazole among HIV-exposed uninfected infants is well tolerated. AIDS. 2012 Jan 28;26(3):325-33. doi: 10.1097/QAD.0b013e32834e892c.
PubMed 22112598
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV-Infected Women to Prevent Vertical HIV Transmission During Breastfeeding
- ClinicalTrials.gov ID
- NCT00074412
- Acronym / sponsor ID
- HPTN 046
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, Treatment Experienced, Treatment Naive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,026 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Jan 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Dec 2003 (estimated)
- Results
- Posted 16 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice, especially in developing countries. The purpose of this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP) in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South Africa, Tanzania, Uganda, and Zimbabwe.
Detailed description
Breastfeeding provides general health, growth, and development benefits to an infant and significantly decreases the risk of certain acute and chronic diseases. Breastfeeding also decreases financial burden on the mother by decreasing the need for infant formula and health care for the infant. However, clinical evidence has shown that HIV can be readily transmitted through breast milk, although the risk of HIV MTCT over time while breastfeeding has been difficult to determine. Given the many advantages of breastfeeding and the significant obstacles to substituting formula for breast milk in developing countries, there is an urgent need to make breastfeeding by HIV infected women safe. This study will evaluate the safety and efficacy of an extended NVP regimen for prevention of MTCT of HIV through breastfeeding.
This study will last approximately 3.5 years. Mother/infant pairs will be enrolled over a period of 18 to 24 months. During the third trimester of pregnancy, HIV infected participants will receive HIV counseling and the intrapartum/neonatal two-dose NVP prophylaxis regimen to prevent MTCT. Mothers will also be given infant feeding options counseling and information on administering the study drug to the infant. Infants who were randomly assigned to receive a placebo and older than 6 weeks of age as of 08/10/07 OR to receive NVP will continue their treatment assignment. Infants who were randomly assigned to receive a placebo and are 6 weeks of age or less as of 08/10/07 will receive open-label NVP through Day 42 of life. For all other participants, all randomized infants will receive extended NVP through 6 weeks (Day 42) of life. All eligible infants will be randomly assigned to one of two groups at Week 6 following birth. The first group will receive extended NVP treatment; the second group will receive nevirapine placebo. Randomized infants will receive the extended NVP or NVP placebo through the first 6 months of life or until cessation of breastfeeding, whichever occurs earlier. Mothers will be instructed to begin giving their infants their assigned intervention starting at Day 3 to Day 7 postpartum. All mothers and infants outside of the study will be offered the local standard of care antiretroviral (ARV) regimen for the prevention of MTCT, but these ARVs will not be provided by the study.
Follow-up evaluations will be conducted at Weeks 2 and 6 and Months 3, 6, 12, and 18 for mothers, and at Weeks 2, 5, 6, and 8 and Months 3, 4, 5, 6, 9, 12, and 18 for infants. Study visits will include physical examinations, blood tests (including HIV tests), and medical histories. Study participants will be followed for up to 3.5 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2A | Experimental | Drug: NevirapineFor infants: extended treatment with NVP |
| 2B | Placebo comparator | Drug: Nevirapine placeboFor infants: extended treatment with NVP placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years of age or older
- HIV infected
- In third trimester of pregnancy, or at most 3 days post-delivery
- If baby is not yet born, planning to deliver at a facility where the study is being conducted
- Plan to breastfeed
Key exclusion criteria (8 listed)
- Complications with this pregnancy
- Serious medical condition that would interfere with the study (e.g., that would prevent breastfeeding or adherence to the follow-up schedule), as judged by the on-site clinician
- HIV DNA PCR positive at birth
- ALT of Grade 2 or higher at birth
- Hemoglobin, absolute neutrophil count, or platelet count of Grade 3 or higher at birth
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 |
|---|---|---|
| NevirapineAlso: NVP10 mg/ml oral suspension taken once daily up to 6 months of age. Dosage will increase throughout study. | Drug | 2A |
| Nevirapine placeboAlso: NVP placeboOral suspension taken once daily up to 6 months of age | Drug | 2B |
Primary outcome
HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study
Time frame: At Month 6
Frequency and Severity of Adverse Reactions Among Participating Infants
Time frame: 6 weeks through 18 months
For those infants who were randomized at 6 weeks and who initiated study drug we looked at the frequency and severity of adverse reactions through 18 months of study. The severity of all AEs was graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. The term severity is described as the intensity grade or level for specific event (i.e. mild, moderate, severe, or life-threatening). Severity is not the same as seriousness.
3 secondary outcomes
Proportion of Infants Who Are Alive and HIV-uninfected in the Two Arms
Time frame: At Months 6 and 18
Relative Rates of HIV Infection in the Two Arms
Time frame: At Month 18
Infant Survival Rates (Mortality Regardless of HIV Infection) in the Two Arms
Time frame: At Month 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 13678973Jackson JB, Musoke P, Fleming T, Guay LA, Bagenda D, Allen M, Nakabiito C, Sherman J, Bakaki P, Owor M, Ducar C, Deseyve M, Mwatha A, Emel L, Duefield C, Mirochnick M, Fowler MG, Mofenson L, Miotti P, Gigliotti M, Bray D, Mmiro F. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial. Lancet. 2003 Sep 13;362(9387):859-68. doi: 10.1016/S0140-6736(03)14341-3.
- Background: PubMed 11249545Mitchla Z, Sharland M. Current treatment options to prevent perinatal transmission of HIV. Expert Opin Pharmacother. 2000 Jan;1(2):239-48. doi: 10.1517/14656566.1.2.239.
- Background: PubMed 14724794Mofenson LM. Advances in the prevention of vertical transmission of human immunodeficiency virus. Semin Pediatr Infect Dis. 2003 Oct;14(4):295-308. doi: 10.1053/j.spid.2003.09.003.
- Background: PubMed 15384577Piwoz EG, Ross J, Humphrey J. Human immunodeficiency virus transmission during breastfeeding: knowledge, gaps, and challenges for the future. Adv Exp Med Biol. 2004;554:195-210.
- Derived from this study: PubMed 37861675Bhattacharya D, Guo R, Tseng CH, Emel L, Sun R, Zhang TH, Chiu SH, Stranix-Chibanda L, Chipato T, Ship H, Mohtashemi NZ, Kintu K, Manji KP, Moodley D, Maldonado Y, Currier JS, Thio CL. Hepatitis B virus clinical and virologic characteristics in an HIV perinatal transmission study in sub-Saharan Africa. AIDS. 2024 Mar 1;38(3):329-337. doi: 10.1097/QAD.0000000000003752. Epub 2023 Oct 17.
- Derived from this study: PubMed 33181788Bhattacharya D, Guo R, Tseng CH, Emel L, Sun R, Chiu SH, Stranix-Chibanda L, Chipato T, Mohtashemi NZ, Kintu K, Manji KP, Moodley D, Thio CL, Maldonado Y, Currier JS. Maternal HBV Viremia and Association With Adverse Infant Outcomes in Women Living With HIV and HBV. Pediatr Infect Dis J. 2021 Feb 1;40(2):e56-e61. doi: 10.1097/INF.0000000000002980.
- Derived from this study: PubMed 25222119Nandlal V, Moodley D, Grobler A, Bagratee J, Maharaj NR, Richardson P. Anaemia in pregnancy is associated with advanced HIV disease. PLoS One. 2014 Sep 15;9(9):e106103. doi: 10.1371/journal.pone.0106103. eCollection 2014.
- Derived from this study: PubMed 24189151Fowler MG, Coovadia H, Herron CM, Maldonado Y, Chipato T, Moodley D, Musoke P, Aizire J, Manji K, Stranix-Chibanda L, Fawzi W, Chetty V, Msweli L, Kisenge R, Brown E, Mwatha A, Eshleman SH, Richardson P, Allen M, George K, Andrew P, Zwerski S, Mofenson LM, Jackson JB; HPTN 046 Protocol Team. Efficacy and safety of an extended nevirapine regimen in infants of breastfeeding mothers with HIV-1 infection for prevention of HIV-1 transmission (HPTN 046): 18-month results of a randomized, double-blind, placebo-controlled trial. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):366-74. doi: 10.1097/QAI.0000000000000052.
- Derived from this study: PubMed 22196945Coovadia HM, Brown ER, Fowler MG, Chipato T, Moodley D, Manji K, Musoke P, Stranix-Chibanda L, Chetty V, Fawzi W, Nakabiito C, Msweli L, Kisenge R, Guay L, Mwatha A, Lynn DJ, Eshleman SH, Richardson P, George K, Andrew P, Mofenson LM, Zwerski S, Maldonado Y; HPTN 046 protocol team. Efficacy and safety of an extended nevirapine regimen in infant children of breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1 transmission (HPTN 046): a randomised, double-blind, placebo-controlled trial. Lancet. 2012 Jan 21;379(9812):221-8. doi: 10.1016/S0140-6736(11)61653-X. Epub 2011 Dec 22.
- Derived from this study: PubMed 22112598Aizire J, Fowler MG, Wang J, Shetty AK, Stranix-Chibanda L, Kamateeka M, Brown ER, Bolton SG, Musoke PM, Coovadia H. Extended prophylaxis with nevirapine and cotrimoxazole among HIV-exposed uninfected infants is well tolerated. AIDS. 2012 Jan 28;26(3):325-33. doi: 10.1097/QAD.0b013e32834e892c.
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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.
Hoosen M. Coovadia, MD, MBBS study chair
Centre for HIV Networking (HIVAN), Nelson Mandela School of Medicine, University of Natal
Laura Guay, MD study chair
Johns Hopkins University
Wafaie Fawzi, MD, PhD study chair
Department of Nutrition, Harvard School of Public Health
5 sites in 4 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, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 4 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 10 inclusion and 8 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 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Zimbabwe, South Africa, Tanzania, Uganda. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study (time frame: At Month 6). The study lists 2 primary outcomes in all. 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 NCT00074412, which also lists 10 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 16 Feb 2023.