Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
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ClinicalTrials.gov Identifier: NCT00115648 |
Recruitment Status
:
Completed
First Posted
: June 24, 2005
Last Update Posted
: March 7, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Nevirapine Drug: AZT Drug: NVP and AZT Drug: NVP Drug: NVP+AZT | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 3300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | October 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: A
Single dose NVP + ZDV daily for the first week.
|
Drug: Nevirapine
Oral NVP daily dosage
Drug: AZT
Oral AZT daily
Other Name: Zidovuidne (ZDV)
Drug: NVP and AZT
Oral single dose NVP plus oral daily AZT during the first weeks
Other Name: Nevirapine and zidovudine
|
Experimental: C
Arm A plus NVP + ZDV daily to age 14 weeks.
|
Drug: Nevirapine
Oral NVP daily dosage
Drug: AZT
Oral AZT daily
Other Name: Zidovuidne (ZDV)
Drug: NVP+AZT
Oral NVP daily plus oral AZT daly to age 14 weeks
Other Name: Nevirapine plus zidovudine
|
Experimental: B
Arm A plus oral NVP daily to age 14 weeks.
|
Drug: Nevirapine
Oral NVP daily dosage
Drug: NVP
Oral NVP daily to age 14 weeks
Other Name: Nevirapine
|
- 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 ]
- To determine overall infant survival rates at 6, 12, 18 and 24 months. [ Time Frame: 6,12,18 & 24 months ]

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Ages Eligible for Study: | 18 Years to 54 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115648
Malawi | |
College of Medicine | |
Blantyre, Malawi, 1331 |
Principal Investigator: | Taha E Taha, MD PhD | Johns Hopkins Bloomberg School of Public Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Michael Thigpen, Medical Officer, Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00115648 History of Changes |
Other Study ID Numbers: |
PEPI-Malawi |
First Posted: | June 24, 2005 Key Record Dates |
Last Update Posted: | March 7, 2014 |
Last Verified: | March 2014 |
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
HIV MTCT Infants africa HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Zidovudine Nevirapine |
Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |