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Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy Clinical research trials and Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy. Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy clinical trial. Human subjects often receive the most effective healthcare possible for their Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy  Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy
Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy
For Condition: Pregnancy,HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: The best anti-HIV treatment regimen for pregnant women is not known. Protease inhibitors (PIs) are often used, but they have side effects that may be harmful for pregnant women. It is not known if treatment regimens that do not include PIs are as effective in pregnant women as those that include PIs. This trial will compare two anti-HIV treatment plans, one with and one without PIs, in women who start HIV treatment during pregnancy. The study will evaluate the effects of the anti-HIV drugs on the developing infant and prevention of mother-to-child HIV transmission during pregnancy.
Details: The optimal treatment strategy for women who initiate antiretroviral therapy during pregnancy is not known. Although PI-based antiretroviral regimens are prescribed with increasing frequency among pregnant women, the efficacy and safety of this approach is unknown. Pregnant women are at increased risk for glucose intolerance and insulin resistance; PIs are associated with glucose intolerance. Physiologic differences between pregnant women and nonpregnant adults may alter the pharmacokinetics of antiretroviral regimens. Fetal safety considerations and effects on perinatal HIV transmission must also be considered when selecting an antiretroviral regimen for pregnant women. This trial will compare PI-based and PI-sparing antiretroviral regimens for women initiating antiretroviral therapy in pregnancy. Women will be stratified on the basis of viral load (50,000 or less copies/ml or greater than 50,000 copies/ml) and gestational age at entry (20 or less weeks or greater than 20 weeks) and then randomized to one of two treatment groups. Group A will receive the PI nelfinavir (NFV) with zidovudine (ZDV) and lamivudine (d4T); Group B will receive nevirapine (NVP) with ZDV and d4T. Women will have clinic visits for physical and obstetrical examinations at 2, 4, 6, and 8 weeks after entry and then every 4 weeks until delivery. After delivery, infants in both groups may receive ZDV until they are 6 weeks old. Infants are evaluated for safety and to test the infant's blood for HIV-1 at birth and at Weeks 2, 8, 16, and 24. Women will continue on assigned antiretroviral therapy postpartum and will have 11 postpartum clinic visits over a period of 2 years. Blood samples from women will be evaluated for safety and for virologic, pharmacokinetic, and metabolic studies. The first 12 women randomized to Group A will undergo a 4-hour pharmacokinetic profile at 32 to 36 weeks gestation and at 8 weeks postpartum to determine the timing of the nelfinavir trough. The first 20 women randomized to Group B will undergo an 8-hour pharmacokinetic profile at either 16 to 24 weeks or 32 to 36 weeks gestation and then again at 8 weeks postpartum to characterize pharmacokinetics of nevirapine at steady state in pregnancy and in the postpartum period.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 14 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria - HIV infected - 10 to 30 weeks pregnant - Plan to continue pregnancy - HIV RNA load > 1,000 copies/ml within 30 days of study entry - No previous anti-HIV therapy (except ZDV for <= 8 weeks, including prior pregnancy) - Willing to follow study requirements and plan to continue receiving anti-HIV treatment for at least 2 years after delivery - Understand that NFV will not be supplied by the study (except for the first 12 women in Group A) - Understand the study drug NVP will not be supplied after 1 year following delivery and is reasonably certain that she can obtain NVP by prescription for the second year of the study - Access to a participating site - Willing to have infant followed until 24 weeks old Exclusion Criteria - Alcohol or drug abuse - Chemotherapy for an active cancer - AIDS-related opportunistic infection and/or serious bacterial infection or unstable or serious medical condition within 14 days of study entry - Chronic malabsorption or diarrhea - Diabetes, unless it only occurs during pregnancy - Major fetal problem or abnormality - Abnormal amniotic fluid volume - Plan to breastfeed - Acute hepatitis within 90 days of study entry - Skin problems such as psoriasis or eczema that require systemic treatment - Serious disease that, in the opinion of the study official, would compromise study participation
Total Enrollment: 440
Location and Contact Information:
Overall Study Official:
JaneHitti, Study Chair, University of Washington
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 60637-1470
United States
Montefiore Medical / AECOM
Bronx, New York, 19461
United States
New York Univ School of Medicine
New York City, New York, 10016
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Johns Hopkins Univ (Pediatric)
Baltimore, Maryland, 21287-4933
United States
Childrens Hosp of Boston
Boston, Massachusetts, 02115
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Hosp dos Servidores do Estado
Rio de Janeiro, , 22261-161
Brazil
The Med Ctr Inc
Columbus, Georgia, 31901
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Univ of Washington Med Ctr
Seattle, Washington, 98105-0371
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02478
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Princess Margaret Hosp
Nassau, New Providence Island,
Bahamas
MetroHealth Med Ctr
Cleveland, Ohio, 44109-1998
United States
Yale Univ School of Medicine
New Haven, Connecticut, 06504
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Vanderbilt University Med Ctr
Nashville, Tennessee, 38105
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Univ Hosp
New Orleans, Louisiana, 70112-2699
United States
Univ of California, San Diego
San Diego, California, 92103
United States
Tulane Univ., Charity Hosp of New Orleans
New Orleans, Louisiana, 70112-2699
United States
The Regional Medical Ctr, Memphis
Memphis, Tennessee, 38105
United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
United States
Oregon Health and Science Univ
Seattle, Washington, 98105-0371
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Northwest Family Ctr/Harborview Med Ctr
Seattle, Washington, 98105-0371
United States
The Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
University of Rochester
Rochester, New York, 14642
United States
SUNY Upstate Med Univ
Syracuse, New York, 13210
United States
Children's Hosp and Regional Med Ctr
Seattle, Washington, 98105-0371
United States
Harbor - UCLA Med Ctr
Torrance, California, 90509
United States
Childrens Hosp of Michigan
Detroit, Michigan, 48201
United States
Additional Information:
Study ID Numbers: ACTG P1022; PACTG P1022
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017719
Other Pregnancy Studies:
1. Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women
2. A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
3. Study for Future Families
4. Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
5. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants
Related Studies:
Other Pregnancy Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy
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