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A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies Clinical research trials and A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies clinical trial. Subjects frequently obtain the most expert healthcare possible for their A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies  A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies
A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies
For Condition: HIV Infections,Pregnancy
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their babies can help reduce the chance that a mother will give HIV to her baby during delivery. Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies.
Details: NVP has several properties that make it an attractive candidate for antiretroviral therapy to interrupt HIV-1 transmission in the intrapartum and early post-partum period. The pharmacokinetic profile suggests that NVP would be rapidly absorbed and transferred to the infant in utero when given during labor and delivery. The HIV-1 antiviral activity is rapid with significant reduction in plasma virus occurring within a few days of drug administration. In addition, NVP has been shown to penetrate cell-free virions and inactivate virion-associated RT in situ. This property would be potentially useful in inactivating cell-free virions in the genital tract as well as in breast milk. These characteristics of NVP suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of NVP may provide a prophylactic level of NVP in the infant during the time of exposure to virus in the birth canal and/or maternal blood. In addition, NVP may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk. Mothers are randomized to receive either a single oral dose of NVP during labor or the corresponding NVP placebo. Randomization occurs at any time after the 28th week of gestation. To assure balance between the treatment groups, the randomization is stratified using 2 factors: 1) use of antiretroviral therapy during the current pregnancy (no antiretroviral therapy at all; monotherapy [with no multi-agent therapy] for any duration; multi-agent therapy for any duration), and 2) CD4 cell count at the time of randomization (less than 200 cells; 200 to 399 cells; 400 cells or greater). Mothers are followed on-study for 4 to 6 weeks postpartum. Due to the results of ACTG 076 and 185, all women for entry into ACTG 316 are encouraged to incorporate a regimen of zidovudine (ZDV) into their current treatment regimen and should continue ZDV during delivery and to their neonates (for at least 6 weeks post-birth). Infants receive a single oral dose of NVP (or the corresponding placebo) administered between 48 and 72 hours of life. The infant's study drug is the same as the mother's randomized treatment assignment. Infants are dosed with study drug according to their randomization group regardless of whether the mother received study drug or not. Infants are followed for 6 months of life, and are tested for HIV at birth, 4 to 6 weeks of life, 3 months of life, and 6 months of life.
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are an HIV-positive pregnant woman. - Have been pregnant for at least 28 weeks. - Are at least 13 years of age (consent of parent or guardian is required if under 18). Exclusion Criteria You will not be eligible for this study if: - Your baby will not live. - You intend to breast-feed. - You are allergic to benzodiazepines (a tranquilizer). - You have a liver disorder. - You have received non-nucleoside reverse transcriptase inhibitors (a class of anti-HIV drugs).
Total Enrollment: 1244
Location and Contact Information:
Overall Study Official:
AlejandroDorenbaum, Study Chair,
Universita Frederico II
Napoli, ,
Italy
Hopital Hotel Dieu de Lyon
Lyon, ,
France
Princess Margaret Hosp
Nassau, ,
Bahamas
CHRU de Nantes
Nantes, ,
France
Hosp Doce De Octubre
Madrid, ,
Spain
Additional Information:
Study ID Numbers: ACTG 316A;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000942
Other Hiv Infections Studies:
1. A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients with AIDS or AIDS-Related Syndromes
2. The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children
3. Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune System's Response to HIV
4. A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients
5. A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
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A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies
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