This study will look at how well the OraQuick HIV 1/2 Antibody rapid test works and how women accept being tested for HIV late in pregnancy and during labor. For women with positive test results, the study will look at whether or not these women accept anti-HIV drugs and which drugs they receive.

Condition
HIV Infections

Further Study Details: 

Expected Total Enrollment:  7500

A simple HIV test design and easily interpretable, fast results are logistical advantages in clinical settings such as the labor and delivery unit. A fast test result means that a woman can make important choices about her and her baby's medical care before she delivers her baby. If a woman finds out she has HIV, she can decide to take antiretroviral drugs before delivery to decrease the risk of passing HIV to her baby. These advantages are also important for women with little or no prenatal care who present for care late in pregnancy, but may not be inclined to return for a standard test result or adhere to subsequent prenatal visits.

Eligible women who elect to participate in this study will be enrolled in either the Late Presenter Group (women who are not in active labor, and for whom delivery is not imminent) or the Peripartum Group (women who are in active labor with anticipation of delivery within 24 hours). Step I for all women will include rapid HIV testing with OraQuick HIV 1/2 and standard testing with enzyme-linked immunosorbant assay (EIA) or Western blot. Women with a positive HIV test and their infants will be offered preventative antiretroviral therapy and enrollment into Step II. Step II will include clinical evaluations, laboratory evaluations, and an adherence assessment for the women and their infants. Women in the Late Presenter Group who participate in Step II will have one prenatal visit, a visit at labor and delivery, and three postpartum visits. Women in the Peripartum Group who participate in Step II will have three postpartum visits. All infants in Step II will have five study visits through 24 weeks of age.

All antiretroviral drugs will be obtained by prescription and will not be provided through this study.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

INCLUSION CRITERIA

Late Presenter Group:

• Unknown HIV serostatus
• >= 34 weeks gestation

Peripartum Group:

• Unknown HIV serostatus
• >= 24 weeks gestation
• In active labor or delivery expected within 24 hours

Infants:

• Maternal Step I enrollment
• Positive maternal OraQuick and/or EIA/Western blot result

EXCLUSION CRITERIA

Late Presenter Group:

• Previous or current antiretroviral therapy for treatment of HIV infection
• In active labor
• Evidence of ruptured membranes

Peripartum Group:

• Previous or current antiretroviral therapy for treatment of HIV infection

California
      Harbor-UCLA Med Ctr, Torrance,  California,  90509,  United States
District of Columbia
      Howard University Hospital, Washington,  District of Columbia,  United States
Massachusetts
      Univ of Massachusetts Med School, Worcester,  Massachusetts,  01655-0001,  United States
New York
      New York Univ School of Medicine, New York,  New York,  10016,  United States
Pennsylvania
      St. Christophers Hosp for Children, Philadelphia, Philadelphia,  Pennsylvania,  19134,  United States
      Hahnemann University Hospital, Philadelphia,  Pennsylvania,  19102-1192,  United States
Puerto Rico
      San Juan City Hosp, San Juan,  00936-7344,  Puerto Rico
      University of Puerto Rico. Univ Childrens Hospital, San Juan,  00936-5067,  Puerto Rico

Study chairs or principal investigators

Robert Maupin, Jr., MD,  Study Chair,  Louisiana State University   

Study ID Numbers:  PACTG P1031
Record last reviewed:  August 2004
Last Updated:  April 7, 2005
Record first received:  September 30, 2002
ClinicalTrials.gov Identifier:  NCT00046436
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08