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Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns Clinical research trials and Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns. Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns clinical trial. Human subjects often get the best healthcare available for their Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns  Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns
Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns
For Condition: HIV Infections,HIV Seronegativity
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if nevirapine (NVP) or zidovudine (AZT), given to mothers during labor and delivery and to their babies during the first week of life, can reduce the rate of mothers passing HIV to their babies. About 25 percent of HIV-infected mothers pass HIV infection to their babies during labor and delivery. There is an urgent need to find a simpler way to prevent mother-to-infant transmission during labor and delivery. The proposed NVP schedule is simpler and possibly could be used in Uganda.
Details: There is an urgent need to find a safe, effective means of preventing mother-to-infant HIV transmission that would also be applicable and affordable in developing-country settings. The frequency of vertical HIV-1 transmission is estimated to be 25 percent. The proposed trial specifically will test the hypothesis that chemoprophylaxis of the fetus/neonate during labor and delivery and the first week of life may significantly reduce the risk of perinatal HIV-1 transmission. Pregnant women infected with HIV-1 are randomized to 1 of 4 study arms and receive either NVP or its placebo, or AZT or its placebo. Mothers in the NVP group receive a single dose of NVP or placebo at the onset of labor and are followed to 6 to 8 weeks after delivery. Infants born to these mothers receive at 48 to 72 hours post-delivery or discharge, whichever comes first, a regimen of the same treatment (NVP or placebo) given to the mother. Infants are followed for 18 months post-delivery by clinical and laboratory evaluation to determine toxicity, evidence of HIV-1 infection, and clinical disease progression. Mothers in the AZT group receive either a bolus of AZT or its placebo at onset of labor, then doses every 3 hours until delivery, with follow-up to 6 to 8 weeks. Infants begin receiving either a lower dose of AZT or placebo as soon as they can tolerate liquids by mouth, twice daily for 7 days, and are followed for 18 months as in the NVP group.
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Mothers may be eligible for this study if they: - Have been pregnant for more than 32 weeks and are at least 18 years of age. - Are HIV-positive. - Reside within 15 km of Mulago Hospital, the study site. - Infants may be eligible for this study if they: - Are born to mothers enrolled in the study. - Have consent of the mother/guardian and, if available, the father. Exclusion Criteria Mothers will not be eligible for this study if they: - Have a serious infection or illness other than HIV. - Currently take any anti-HIV drugs. - Participate during this pregnancy in another treatment vaccine perinatal trial. - Received NVP or AZT within the last 6 months. - Are allergic to any benzodiazepine. - Abuse alcohol or other drugs. - Have high blood pressure that is not controlled. - Have received any anticoagulants, benzodiazepines other than the study drug, or magnesium sulfate within 2 weeks before being assigned to a study group or delivery. - Infants will not be eligible for this study if: - Their mother is excluded prior to being assigned to a study group.
Total Enrollment: 1500
Location and Contact Information:
Overall Study Official:
BrooksJackson, Study Chair,
Missie Allen
Research Triangle Park, North Carolina, 27709
United States
Additional Information:
Study ID Numbers: HIVNET 012;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006396
Other Hiv Seronegativity Studies:
1. Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis carinii Pneumonia
2. Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
3. A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
4. A Study of Mitoguazone Dihydrochloride in Patients with AIDS-Related Non-Hodgkin's Lymphoma
5. A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002
Related Studies:
Other HIV Seronegativity Clinical Trials
Other North Carolina Clinical Trials
Other Research Triangle Park Clinical Trials
Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns
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