The Safety of Nevirapine When Given to Breast-Feeding Babies From Birth to Age 6 Months

NCT00006279 | Completed Phase 1

• 2 other identifiers: HIVNET 02311720
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if it is safe to give nevirapine (NVP) to breast-feeding babies from birth to the age of 6 months and to determine what dose of NVP should be given. Breast-feeding has been shown to be very important for the physical and mental health of infants. This is especially true during the first 6 months of life. However, an HIV-positive mother can pass the virus on to her baby by breast-feeding. Because of this risk, HIV-positive mothers are encouraged to formula-feed, not breast-feed, their babies. In developing countries, however, some women cannot afford to formula-feed. If they do formula-feed, these women risk exposing their HIV status. These women have great need for methods that can lower the chance that they will pass HIV on to their babies. This study will test NVP as a way of doing this.

Conditions

HIV Infections

Keywords

Pregnancy Complications, Infectious; Dose-Response Relationship, Drug; Drug Administration Schedule; Nevirapine; Disease Transmission, Vertical; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Breast Feeding

Interventions

Nevirapine DRUG

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers may be eligible for this study if they:
• Receive prenatal care at King Edward VIII Hospital, Durban, or St. Mary's Hospital, Marianhill, South Africa; or polyclinics in Chitungwiza District, Zimbabwe.
• Are pregnant for at least 30 weeks before giving birth.
• Are at least 18 years of age.
• Are HIV-positive by 2 ELISA tests.
• Have no serious current or previous problems in pregnancy (e.g., seizures).
• Have a fixed home and/or work address.
• Plan to deliver the baby at a hospital or clinic where the study is based.
• Plan to breast-feed their babies.
• Infants may be eligible for this study if they:
• Are born to women participating in this study.
• Weigh at least 2.5 kg at birth.
• Begin breast-feeding by 48 hours.

You may not qualify if:

• Mothers will not be eligible for this study if they:
• Have AIDS or any other serious illness.
• Are using illegal drugs or have been using alcohol for a long time.
• Are sensitive to NVP.
• Have taken any nonnucleoside reverse transcriptase inhibitors in the past.
• Are using rifampin, rifabutin, ketoconazole, macrolides, or cimetidine.
• Infants will not be eligible for this study if they:
• Have jaundice (yellowing of the skin and whites of eyes) that requires a blood transfusion.
• Have any serious or life-threatening condition(s).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Kathy George

Durham, North Carolina, 27713, United States

Location

Related Publications (2)

• Lee EJ, Kantor R, Zijenah L, Sheldon W, Emel L, Mateta P, Johnston E, Wells J, Shetty AK, Coovadia H, Maldonado Y, Jones SA, Mofenson LM, Contag CH, Bassett M, Katzenstein DA; HIVNET 023 Study Team. Breast-milk shedding of drug-resistant HIV-1 subtype C in women exposed to single-dose nevirapine. J Infect Dis. 2005 Oct 1;192(7):1260-4. doi: 10.1086/444424. Epub 2005 Aug 23.

  PMID: 16136470 RESULT

• Shetty AK, Coovadia HM, Mirochnick MM, Maldonado Y, Mofenson LM, Eshleman SH, Fleming T, Emel L, George K, Katzenstein DA, Wells J, Maponga CC, Mwatha A, Jones SA, Abdool Karim SS, Bassett MT; HIVNET 023 Study Team. Safety and trough concentrations of nevirapine prophylaxis given daily, twice weekly, or weekly in breast-feeding infants from birth to 6 months. J Acquir Immune Defic Syndr. 2003 Dec 15;34(5):482-90. doi: 10.1097/00126334-200312150-00006.

  PMID: 14657758 RESULT

MeSH Terms

Conditions

HIV Infections; Pregnancy Complications, Infectious; Breast Feeding

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hoosen Coovadia

  STUDY CHAIR

• Mary Bassett

  STUDY CHAIR

• Salim Karim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2000
• First Posted: August 31, 2001
• Study Completion: May 1, 2005
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (1)