Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
This study has been completed.
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborators:
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00115648
First received: June 23, 2005
Last updated: March 6, 2014
Last verified: March 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Nevirapine Drug: AZT Drug: NVP and AZT Drug: NVP Drug: NVP+AZT |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins Bloomberg School of Public Health:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine overall infant survival rates at 6, 12, 18 and 24 months. [ Time Frame: 6,12,18 & 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3300 |
| Study Start Date: | April 2004 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Single dose NVP + ZDV daily for the first week.
|
Drug: Nevirapine
Oral NVP daily dosage
Other Name: Nevirapine
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
Other Name: Nevirapine
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
Other Name: Nevirapine
Drug: NVP
Oral NVP daily to age 14 weeks
Other Name: Nevirapine
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 54 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115648
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115648
Locations
| Malawi | |
| College of Medicine | |
| Blantyre, Malawi, 1331 | |
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
| Principal Investigator: | Taha E Taha, MD PhD | Johns Hopkins Bloomberg School of Public Health |
More Information
No publications provided by Johns Hopkins Bloomberg School of Public Health
Additional 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 |
| Study First Received: | June 23, 2005 |
| Last Updated: | March 6, 2014 |
| Health Authority: | Malawi: College of Medicine Research and Ethics Committee |
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
|
HIV MTCT Infants africa HIV Seronegativity |
Additional relevant MeSH terms:
|
Nevirapine Zidovudine Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antimetabolites Antiviral Agents |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015