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Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV Clinical research trials and Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV. Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV clinical trial. Participants typically obtain the most effective healthcare available for their Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "N" Clinical Trials Conditions > Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV  Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV
Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission.
Details: The use of antiretroviral therapy during late pregnancy, intrapartum, and immediately postpartum prevents a high proportion of vertical transmission. Potential means of decreasing HIV transmission through breastfeeding, along with the risks and benefits of early weaning, need to be further evaluated. The potential impact of early weaning interventions on the breastfeeding habits of the HIV uninfected population needs to be considered as well. This study seeks to identify a way to make breastfeeding safe for HIV infected women who choose to breastfeed. A single dose of NVP given to infants of HIV infected mothers appears to provide some protection against vertical transmission. NVP’s long half-life allows simple dosing, making it more feasible and affordable to implement in a developing country. This study will determine whether extending the NVP dosing to six weeks will significantly decrease transmission during the first several months of breastfeeding.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - HIV infection, documented on two separate specimens - Estimated gestational age at enrollment of 32 weeks or more as indicated by last menstrual cycle and fundal height - Permanent residency in Addis Ababa - Plan to deliver at a hospital affliated with the study (Tikur Anbessa Hospital, Gandhi hospital, or St. Paul's Hospital) - Hemoglobin >= 7.5 gm/dl within 4 weeks prior to study entry - Serum glutamic pyruvic transaminase (SGPT) < 5 times upper limit of normal within 4 weeks prior to study entry - Serum creatinine < 1.5 mg/dl within 4 weeks prior to study entry - Consent form signed by the mother and, when possible, by the father, prior to the onset of labor
Total Enrollment: 1912
Location and Contact Information:
Tikur Anbessa Hospital *Recruiting*
Addis Abeba, ,
Ethiopia
Recruiting Abubaker Bedri 251 1 525816
Additional Information:
Study ID Numbers: 5R01AI038576-05; NIGAT Project
Study Start Date: February 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074399
Other Hiv Infections Studies:
1. A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.
2. A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors
3. Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
4. A Study of Immune System Activity in Healthy Adults
5. A Study to Evaluate the Effect of Anti-HIV Therapy on Lean Tissue (Muscle) in HIV-Positive Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Clinical Trials
Other Addis Abeba Clinical Trials
Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV
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