Comparison of Anti-HIV Drug Combinations to Prevent Mother-to-Child Transmission of HIV
NCT ID: NCT00086359
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
19 participants
INTERVENTIONAL
2004-07-31
2007-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Women in this study will be randomly assigned to one of two groups. Women in Group A will receive one pill ABC/3TC/ZDV twice a day. Women in Group B will receive one pill 3TC/ZDV and 4 pills LPV/RTV twice a day. Women will take their assigned medications until they go into labor. Once in labor, women will be given zidovudine through intravenous (IV) infusion; they will stop taking oral zidovudine but will continue with their other medications. After delivery, all infants will be given zidovudine for six weeks.
Women will have study visits every 2 weeks for the first 8 weeks of treatment, and then every 4 weeks until Week 28. Depending on where a woman is in her pregnancy when she enrolls in the study, she will also have study visits at Weeks 20, 28, and 34 of her pregnancy. At each visit, women will have a medical interview, a physical exam, and an obstetrical exam; blood and urine collection will occur at these visits. Mothers will undergo a fetal ultrasound at Week 20. Adherence, health status, and behavior assessments will occur at selected visits prior to delivery.
After delivery, women will stop taking the study medications but will continue to have study visits at approximately 6, 12, 24, 36, 48, and 52 weeks after delivery. Medical history and a physical exam will occur at all visits for mothers postpartum. Blood collection will occur at every postpartum visit; urine collection will occur 12, 24, and 48 weeks postpartum; health status and behavior assessments will occur at most visits postpartum. Infants will have study visits at 2, 16, and 24 weeks after birth. A medical history, physical exam, and laboratory tests will be conducted at the infant study visits. Women will also be asked to enroll their infants in PACTG 219C, a long-term study that follows infants who are born to HIV infected mothers.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
One pill of abacavir/lamivudine/zidovudine twice daily
Abacavir sulfate, lamivudine, and zidovudine
one pill twice daily
B
One pill of zidovudine/lamivudine and four pills of lopinavir/ritonavir twice daily.
Lamivudine/zidovudine
one pill twice daily
Lopinavir/ritonavir
four pills twice daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abacavir sulfate, lamivudine, and zidovudine
one pill twice daily
Lamivudine/zidovudine
one pill twice daily
Lopinavir/ritonavir
four pills twice daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Between the 12th and 30th week of pregnancy
* Intend to continue pregnancy
* Viral load less than 55,000 copies/ml within 30 days of study entry
* CD4 count greater than 350 cells/ml within 30 days of study entry
* Have not previously taken anti-HIV medications (women who have taken 8 weeks or fewer of zidovudine are still eligible) OR have taken anti-HIV medication but have been off treatment for more than 180 days
* Intend to stop taking anti-HIV medications after pregnancy
* Willing to have her infant tested for HIV
* Parent or guardian willing to provide informed consent, if applicable
* Have access to a participating site and are willing to be followed for the duration of the study
Exclusion Criteria
* Active opportunistic infection or severe medical condition within 14 days of study entry
* Chronic diarrhea within 1 month of study entry or unresolved acute diarrhea within 7 days of study entry
* Certain abnormal laboratory values
* Diabetes mellitus when not pregnant. Participants who have gestational diabetes are not excluded.
* Current alcohol or other substance abuse that, in the opinion of the investigator, may interfere with the study
* Acute hepatitis within 90 days of study entry
* Major birth defects in infant
* Severe skin disorder (e.g., eczema or psoriasis) requiring systemic treatment
* Require certain medications
* Medical condition that may, in the opinion of the investigator, interfere with the study
* Intend to breastfeed
13 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew D. Hull, MD
Role: STUDY_CHAIR
Department of Reproductive Medicine, Division of Perinatal Medicine, University of California, San Diego School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Usc La Nichd Crs
Los Angeles, California, United States
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois, United States
Bronx-Lebanon CRS
The Bronx, New York, United States
Regional Med. Ctr. at Memphis
Memphis, Tennessee, United States
Texas Children's Hosp. CRS
Houston, Texas, United States
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cooper ER, Charurat M, Mofenson L, Hanson IC, Pitt J, Diaz C, Hayani K, Handelsman E, Smeriglio V, Hoff R, Blattner W; Women and Infants' Transmission Study Group. Combination antiretroviral strategies for the treatment of pregnant HIV-1-infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr. 2002 Apr 15;29(5):484-94. doi: 10.1097/00126334-200204150-00009.
Scarlatti G. Mother-to-child transmission of HIV-1: advances and controversies of the twentieth centuries. AIDS Rev. 2004 Apr-Jun;6(2):67-78.
Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. doi: 10.1097/00126334-200309011-00010.
Thorne C, Newell ML. Mother-to-child transmission of HIV infection and its prevention. Curr HIV Res. 2003 Oct;1(4):447-62. doi: 10.2174/1570162033485140.
Tuomala RE, Shapiro DE, Mofenson LM, Bryson Y, Culnane M, Hughes MD, O'Sullivan MJ, Scott G, Stek AM, Wara D, Bulterys M. Antiretroviral therapy during pregnancy and the risk of an adverse outcome. N Engl J Med. 2002 Jun 13;346(24):1863-70. doi: 10.1056/NEJMoa991159.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10046
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG P1039
Identifier Type: -
Identifier Source: secondary_id
P1039
Identifier Type: -
Identifier Source: org_study_id