Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV

NCT ID: NCT00074399

Last Updated: 2009-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 775 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2007-04-30

Brief Summary

HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission.

Study hypothesis: Six weeks of nevirapine prophylaxis provided to the infant will decrease HIV transmission through breastfeeding.

Detailed Description

The use of antiretroviral therapy during late pregnancy, intrapartum, and immediately postpartum prevents a high proportion of vertical transmission. Potential means of decreasing HIV transmission through breastfeeding, along with the risks and benefits of early weaning, need to be further evaluated. The potential impact of early weaning interventions on the breastfeeding habits of the HIV uninfected population needs to be considered as well. This study seeks to identify a way to make breastfeeding safe for HIV infected women who choose to breastfeed.

A single dose of NVP given to infants of HIV infected mothers appears to provide some protection against vertical transmission. NVP's long half-life allows simple dosing, making it more feasible and affordable to implement in a developing country. This study will determine whether extending the NVP dosing to six weeks will significantly decrease transmission during the first several months of breastfeeding.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Participants will receive nevirapine for 6 weeks

Group Type: EXPERIMENTAL

Nevirapine

Intervention Type: DRUG

Tablet taken orally daily. Dosage depends on age and body surface area

2

Participants will receive nevirapine placebo for 6 weeks

Group Type: PLACEBO_COMPARATOR

Nevirapine placebo

Intervention Type: DRUG

Placebo tablet taken orally daily

Interventions

Nevirapine

Tablet taken orally daily. Dosage depends on age and body surface area

Intervention Type: DRUG

Nevirapine placebo

Placebo tablet taken orally daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• HIV infection, documented on two separate specimens
• Estimated gestational age at enrollment of 32 weeks or more as indicated by last menstrual cycle and fundal height
• Permanent residency in Addis Ababa
• Plan to deliver at a hospital affliated with the study (Tikur Anbessa Hospital, Gandhi hospital, or St. Paul's Hospital)
• Hemoglobin >= 7.5 gm/dl within 4 weeks prior to study entry
• Serum glutamic pyruvic transaminase (SGPT) < 5 times upper limit of normal within 4 weeks prior to study entry
• Serum creatinine < 1.5 mg/dl within 4 weeks prior to study entry
• Consent form signed by the mother and, when possible, by the father, prior to the onset of labor

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Johns Hopkins University

Locations

Tikur Anbessa Hospital

Addis Ababa, , Ethiopia

Countries

Ethiopia

References

Six Week Extended-Dose Nevirapine (SWEN) Study Team; Bedri A, Gudetta B, Isehak A, Kumbi S, Lulseged S, Mengistu Y, Bhore AV, Bhosale R, Varadhrajan V, Gupte N, Sastry J, Suryavanshi N, Tripathy S, Mmiro F, Mubiru M, Onyango C, Taylor A, Musoke P, Nakabiito C, Abashawl A, Adamu R, Antelman G, Bollinger RC, Bright P, Chaudhary MA, Coberly J, Guay L, Fowler MG, Gupta A, Hassen E, Jackson JB, Moulton LH, Nayak U, Omer SB, Propper L, Ram M, Rexroad V, Ruff AJ, Shankar A, Zwerski S. Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomised controlled trials. Lancet. 2008 Jul 26;372(9635):300-13. doi: 10.1016/S0140-6736(08)61114-9.

Reference Type: DERIVED

PMID: 18657709 (View on PubMed)

Other Identifiers

NIGAT Project

Identifier Type: -

Identifier Source: secondary_id

5R01AI038576-05

Identifier Type: NIH

Identifier Source: org_study_id

View Link