HIV InfectionsPhase 3NCT00115648
Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
A Phase 3 study testing Nevirapine, AZT and NVP and AZT in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Malawi.
Trial summary
The purpose of this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV. Read more about this study
- Who is it for?
- Ages 18 to 54 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine, AZT and NVP and AZT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,300 participants
- Where
- 1 siteMalawi
- Study dates
- Apr 2004to Oct 2009
- 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 18 to 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Had given birth within the last 24 hours
- Ability and willingness to give informed consent for HIV testing and enrollment into the study
- Willing to receive HIV results
- HIV infected
- Planning to deliver or had given birth at the study clinics
- Willing to come back for follow-up visits for 2 years postnatally
- Resident of Blantyre city or its suburbs
Who cannot join
- HIV negative
- Women with discordant HIV results
- Women who indicate that they will not breastfeed at time of delivery
- Inability or unwillingness to follow any of the inclusion requirements
- Newborn with life-threatening condition
- Women who previously enrolled in this study and have a second pregnancy cannot reenroll
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV.
Read the detailed description
This is a three-arm randomized, open label, clinical trial to evaluate the effectiveness of two extended regimens of antiretrovirals compared to infant single dose nevirapine plus AZT given twice daily for 1 week (comparison regimen). All infants receive the comparison regimen at birth and then randomized at birth to start either one of the two extended regimens after the first week. The extended regimens are nevirapine daily and nevirapine plus AZT daily - both regimens are given up to age 14 weeks.
- Conditions
- HIV Infections
- Being tested
- Nevirapine, AZT, NVP and AZT, NVP, NVP+AZT
- Keywords
- HIV, MTCT, Infants, africa, 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.
NevirapineDrug
Oral NVP daily dosage
AZTDrug
Also called Zidovuidne (ZDV)
Oral AZT daily
NVP and AZTDrug
Also called Nevirapine and zidovudine
Oral single dose NVP plus oral daily AZT during the first weeks
NVPDrug
Also called Nevirapine
Oral NVP daily to age 14 weeks
NVP+AZTDrug
Also called Nevirapine plus zidovudine
Oral NVP daily plus oral AZT daly to age 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Single dose NVP + ZDV daily for the first week. Receives: Drug: Nevirapine; Drug: AZT; Drug: NVP and AZT |
| C | Experimental | Arm A plus NVP + ZDV daily to age 14 weeks. Receives: Drug: Nevirapine; Drug: AZT; Drug: NVP+AZT |
| B | Experimental | Arm A plus oral NVP daily to age 14 weeks. Receives: Drug: Nevirapine; Drug: NVP |
What is being measured
The primary outcome is the main question the study is designed to answer.
A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks.
Measured: 9 months
Secondary outcomes (1)
To determine overall infant survival rates at 6, 12, 18 and 24 months.
Measured: 6,12,18 & 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2005 (estimated)
- Study startApr 2004
- Primary completionAug 2007
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Johns Hopkins Bloomberg School of Public HealthThe 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
- None (open label)
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Taha E Taha, MD PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115648
- Sponsor's protocol ID
- PEPI-Malawi
- Status last verified
- Mar 2014
- First submitted
- 23 Jun 2005
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schwartz SR, Kumwenda N, Kumwenda J, Chen S, Mofenson LM, Taylor AW, Fowler MG, Taha TE. Maternal Highly Active Antiretroviral Therapy and Child HIV-Free Survival in Malawi, 2004-2009. Matern Child Health J. 2016 Mar;20(3):542-9. doi: 10.1007/s10995-015-1852-5.
PubMed 26525557Redd AD, Wendel SK, Longosz AF, Fogel JM, Dadabhai S, Kumwenda N, Sun J, Walker MP, Bruno D, Martens C, Eshleman SH, Porcella SF, Quinn TC, Taha TE. Evaluation of postpartum HIV superinfection and mother-to-child transmission. AIDS. 2015 Jul 31;29(12):1567-73. doi: 10.1097/QAD.0000000000000740.
PubMed 26244396Taha TE, Li Q, Hoover DR, Mipando L, Nkanaunena K, Thigpen MC, Taylor A, Kumwenda J, Fowler MG, Mofenson LM, Kumwenda NI. Postexposure prophylaxis of breastfeeding HIV-exposed infants with antiretroviral drugs to age 14 weeks: updated efficacy results of the PEPI-Malawi trial. J Acquir Immune Defic Syndr. 2011 Aug 1;57(4):319-25. doi: 10.1097/QAI.0b013e318217877a.
PubMed 21423025Kumwenda NI, Hoover DR, Mofenson LM, Thigpen MC, Kafulafula G, Li Q, Mipando L, Nkanaunena K, Mebrahtu T, Bulterys M, Fowler MG, Taha TE. Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission. N Engl J Med. 2008 Jul 10;359(2):119-29. doi: 10.1056/NEJMoa0801941. Epub 2008 Jun 4.
PubMed 18525035
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
- ClinicalTrials.gov ID
- NCT00115648
- Acronym / sponsor ID
- PEPI-Malawi
- Conditions
- HIV Infections
- Keywords
- HIV, MTCT, Infants, africa, HIV Seronegativity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 24 Jun 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 this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV.
Detailed description
This is a three-arm randomized, open label, clinical trial to evaluate the effectiveness of two extended regimens of antiretrovirals compared to infant single dose nevirapine plus AZT given twice daily for 1 week (comparison regimen). All infants receive the comparison regimen at birth and then randomized at birth to start either one of the two extended regimens after the first week. The extended regimens are nevirapine daily and nevirapine plus AZT daily - both regimens are given up to age 14 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Nevirapine, Drug: AZT, Drug: NVP and AZTSingle dose NVP + ZDV daily for the first week. |
| C | Experimental | Drug: Nevirapine, Drug: AZT, Drug: NVP+AZTArm A plus NVP + ZDV daily to age 14 weeks. |
| B | Experimental | Drug: Nevirapine, Drug: NVPArm A plus oral NVP daily to age 14 weeks. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Had given birth within the last 24 hours
- Ability and willingness to give informed consent for HIV testing and enrollment into the study
- Willing to receive HIV results
- HIV infected
- Planning to deliver or had given birth at the study clinics
Key exclusion criteria (6 listed)
- HIV negative
- Women with discordant HIV results
- Women who indicate that they will not breastfeed at time of delivery
- Inability or unwillingness to follow any of the inclusion requirements
- Newborn with life-threatening condition
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 |
|---|---|---|
| NevirapineOral NVP daily dosage | Drug | A, B, C |
| AZTAlso: Zidovuidne (ZDV)Oral AZT daily | Drug | A, C |
| NVP and AZTAlso: Nevirapine and zidovudineOral single dose NVP plus oral daily AZT during the first weeks | Drug | A |
| NVPAlso: NevirapineOral NVP daily to age 14 weeks | Drug | B |
| NVP+AZTAlso: Nevirapine plus zidovudineOral NVP daily plus oral AZT daly to age 14 weeks | Drug | C |
Primary outcome
A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks.
Time frame: 9 months
1 secondary outcome
To determine overall infant survival rates at 6, 12, 18 and 24 months.
Time frame: 6,12,18 & 24 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 7 Mar 2014.
- Derived from this study: PubMed 26525557Schwartz SR, Kumwenda N, Kumwenda J, Chen S, Mofenson LM, Taylor AW, Fowler MG, Taha TE. Maternal Highly Active Antiretroviral Therapy and Child HIV-Free Survival in Malawi, 2004-2009. Matern Child Health J. 2016 Mar;20(3):542-9. doi: 10.1007/s10995-015-1852-5.
- Derived from this study: PubMed 26244396Redd AD, Wendel SK, Longosz AF, Fogel JM, Dadabhai S, Kumwenda N, Sun J, Walker MP, Bruno D, Martens C, Eshleman SH, Porcella SF, Quinn TC, Taha TE. Evaluation of postpartum HIV superinfection and mother-to-child transmission. AIDS. 2015 Jul 31;29(12):1567-73. doi: 10.1097/QAD.0000000000000740.
- Derived from this study: PubMed 21423025Taha TE, Li Q, Hoover DR, Mipando L, Nkanaunena K, Thigpen MC, Taylor A, Kumwenda J, Fowler MG, Mofenson LM, Kumwenda NI. Postexposure prophylaxis of breastfeeding HIV-exposed infants with antiretroviral drugs to age 14 weeks: updated efficacy results of the PEPI-Malawi trial. J Acquir Immune Defic Syndr. 2011 Aug 1;57(4):319-25. doi: 10.1097/QAI.0b013e318217877a.
- Derived from this study: PubMed 18525035Kumwenda NI, Hoover DR, Mofenson LM, Thigpen MC, Kafulafula G, Li Q, Mipando L, Nkanaunena K, Mebrahtu T, Bulterys M, Fowler MG, Taha TE. Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission. N Engl J Med. 2008 Jul 10;359(2):119-29. doi: 10.1056/NEJMoa0801941. Epub 2008 Jun 4.
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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.
Taha E Taha, MD PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nevirapine, AZT and NVP and AZT in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Malawi.
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 7 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 7 Mar 2014. 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 Malawi. 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.
What does the primary outcome measure?
A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks. (time frame: 9 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 NCT00115648, which also lists 4 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 7 Mar 2014.