Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission

Study Overview
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Brief Summary
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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
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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.

Official Title
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Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Nevirapine
* Drug: AZT
* Drug: NVP and AZT
* Drug: NVP
* Drug: NVP+AZT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Single dose NVP + ZDV daily for the first week. | Drug: Nevirapine<br>* Oral NVP daily dosage<br>Drug: AZT<br>* Oral AZT daily<br>* Other names: Zidovuidne (ZDV);Drug: NVP and AZT<br>* Oral single dose NVP plus oral daily AZT during the first weeks<br>* Other names: Nevirapine and zidovudine;|
| Experimental: C<br>Arm A plus NVP + ZDV daily to age 14 weeks. | Drug: Nevirapine<br>* Oral NVP daily dosage<br>Drug: AZT<br>* Oral AZT daily<br>* Other names: Zidovuidne (ZDV);Drug: NVP+AZT<br>* Oral NVP daily plus oral AZT daly to age 14 weeks<br>* Other names: Nevirapine plus zidovudine;|
| Experimental: B<br>Arm A plus oral NVP daily to age 14 weeks. | Drug: Nevirapine<br>* Oral NVP daily dosage<br>Drug: NVP<br>* Oral NVP daily to age 14 weeks<br>* Other names: Nevirapine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine overall infant survival rates at 6, 12, 18 and 24 months. |  | 6,12,18 & 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, MTCT, Infants, africa, HIV Seronegativity