A Prospective, Observational Study of HIV-Infected Pregnant Women and Their Infants at Clinical Sites in Latin American and Caribbean Countries

NCT00341302 | Completed

• 2 other identifiers: 99990226102-CH-N261
• Study Type: observational
• Target: 3,554
• Locations: 3 countries
• Sites: 12

Brief Summary

By the end of 1999, it was estimated that 1.2 million children were living with HIV infection. During 1999 alone, 600,000 children were newly infected with HIV, mostly in less-developed countries. Most HIV-infected children are infected by transmission from mother to child during pregnancy, at birth, or through breast milk. Antiretroviral medications, cesarean section before rupture of membranes, and avoidance of breastfeeding are ways to reduce the risk of transmission. This study will determine mother-to-child transmission rates and the effects on infants of exposure to antiretroviral medications and mode of delivery. Approximately 180 to 240 HIV-infected pregnant women in Mexico and Argentina will be enrolled during the first year of this 5-year study. HIV-infected women will be evaluated during pregnancy, during delivery, and 6 months after delivery. At each visit, a history will be taken and physical examination given; blood will be collected for laboratory tests. HIV-exposed infants will be evaluated through 6 months of age. At each of 2 visits, a history will be taken and physical examination given; blood will be collected for laboratory tests; and growth will be assessed.

Conditions

Pregnant HIV Positive Women

Keywords

HIV; AIDS; Perinatal; Transmission; Outcomes

Outcome Measures

Primary Outcomes (2)

• To describe the characteristics of HIV-infected pregnant women and their HIV-exposed children in Latin America, including the rates of and risk factors for mother-to-child transmission

  To describe the characteristics of HIV-infected pregnant women and their HIV-exposed children in Latin America, including the rates of and risk factors for mother-to-child transmission.

  in utero, six weeks

• To characterize adverse events according to receipt of and exposure to ARVs (by HIV- infected women during pregnancy and postpartum and by their HIV-exposed but uninfected children in utero and during the first few week

  To characterize adverse events according to receipt of and exposure to ARVs (by HIV- infected women during pregnancy and postpartum and by their HIV-exposed but uninfected children in utero and during the first few week

  in utero, six weeks

Study Arms (3)

Cohort 1

HIV Infected Pregnant Women

Pediatric Cohort 2

HIV exposed , uninfected children born to HIV infected women

Pediatric Cohort 3

HIV exposed, uninfected children 6 months to 5 years of age

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV -infected pregnant women and HIV exposed, uninfected children followed at participating Latin American sites@@@@@@

You may qualify if:

• Pregnant women at 22 weeks of gestation or more with documentation of pregnancy, using one or more of the following:
• Urine HCG pregnancy test;
• Serum HCG pregnancy test;
• Positive fetal heart tones by Doppler; or
• Ultrasound.
• Documentation of HIV infection, defined by any two of the following prior to or during pregnancy:
• Reactive test for HIV antibody;
• Positive HIV culture;
• Positive HIV DNA PCR;
• Positive neutralizable HIV p24 antigen;
• Positive qualitative HIV RNA;
• Quantitative HIV RNA greater than or equal to 1000 copies/ml; and
• Diagnosis of AIDS-defining clinical condition.
• Willingness and intent to deliver at the participating clinical site and to be followed through six months postpartum at the site or associated outpatient facility.
• Willingness and ability to sign informed consent-Subject must be of an age to provide legal informed consent as defined by the country in which the subject resides.

You may not qualify if:

• HIV infection of the child
• Insufficient documentation of HIV infection in the mother obtained either prior to or during pregnancy or within one month postpartum.
• Insufficient evidence of HIV infection in the mother
• Insufficient perinatal data
• Incomplete data regarding maternal medications received during pregnancy (e.g., missing start and stop dates).
• Incomplete data regarding postnatal ARV exposure.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (12)

Hospital General de Agudos "Jose Maria Ramos Mejia"

Buenos Aires, Argentina

Location

Universidade de Caxias do Sul

Caxias do Sul, Brazil

Location

Universidade Federal de Minas Gerais

Minas Gerais, Brazil

Location

Hospital Geral Nova de Iguacu Setor De DST/AIDS

Nova Iguaçu, Brazil

Location

Hospital Conceicao

Porto Alegre, Brazil

Location

Hospital Femina

Porto Alegre, Brazil

Location

Irmandade Da Santa Casa de Misericordia de

Porto Alegre, Brazil

Location

Hospital dos Servidores do Estado - RJ

Rio de Janeiro, Brazil

Location

Instituto de Puericultura e Pediatria

Rio de Janeiro, Brazil

Location

Federal University of Sao Paulo-Escola Paulista de Medicina

São Paulo, Brazil

Location

Hospital das Clinicas da Falculdade De Medinica

São Paulo, Brazil

Location

Unversity of San Marcos

Lima, Peru

Location

Related Publications (3)

• Rates of mother-to-child transmission of HIV-1 in Africa, America, and Europe: results from 13 perinatal studies. The Working Group on Mother-To-Child Transmission of HIV. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Apr 15;8(5):506-10. doi: 10.1097/00042560-199504120-00011.

  PMID: 7697448 BACKGROUND

• U.S. Public Health Service recommendations for human immunodeficiency virus counseling and voluntary testing for pregnant women. MMWR Recomm Rep. 1995 Jul 7;44(RR-7):1-15.

  PMID: 7565546 BACKGROUND

• Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O'Sullivan MJ, VanDyke R, Bey M, Shearer W, Jacobson RL, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994 Nov 3;331(18):1173-80. doi: 10.1056/NEJM199411033311801.

  PMID: 7935654 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Nahida A Chakhtoura, M.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: July 25, 2002
• Primary Completion: November 30, 2011
• Study Completion: July 28, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

PE (1); AR (1); BR (10)