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A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants Clinical research trials and A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants. A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants  A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants
A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants
For Condition: HIV Infections,Pregnancy
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 purpose of this study is to determine if a combination anti-HIV drug treatment regimen of indinavir plus lamivudine (3TC) plus zidovudine (ZDV) is effective in treating HIV and in reducing the chances of passing HIV from mother to child. This study will also examine if this combination is well tolerated by HIV-positive pregnant women and if a combination of 3TC plus ZDV is safe for newborns. Previous studies in adults and children have shown that indinavir plus 3TC plus ZDV can reduce the amount of HIV in the blood. Most HIV-positive pregnant women usually take ZDV to treat HIV and to reduce the chances of giving HIV to their babies. The combination of drugs in this study may be more effective than ZDV alone.
Details: Despite the dramatic reduction of perinatal HIV transmission following the administration of ZDV to mothers and infants, new, more effective strategies are needed. An increasing number of women may require combination antiretroviral therapy for their own disease because they may be resistant to ZDV, may have high viral loads, or may have previously transmitted HIV to an infant while on ZDV monotherapy. The initiation of triple combination therapy, including a protease inhibitor indinavir, during gestation may be the most effective in reducing maternal virus load prior to delivery, thereby potentially benefitting both mother and child. Women: Antepartum (until active labor): Indinavir plus 3TC plus ZDV. Intrapartum (active labor until cord clamping): 3TC plus ZDV. Postpartum (after cord clamped to 12 weeks): Indinavir plus 3TC plus ZDV. Infants: 3TC plus ZDV as soon as oral intake is tolerated (preferably within 12 hours of birth) and continuing for 6 weeks. [AS PER AMENDMENT 1/27/99: For maternal dosing, one Combivir tablet bid can be substituted for the individual formulation of 3TC and ZDV. For mothers who receive Combivir during the antepartum period, Combivir is held during labor and delivery, and the separate formulations of ZDV and 3TC are used. Patients who prematurely discontinue study treatment should continue to be followed on study for the duration of the study.]
Eligibility:
Study Type: Interventional, Prevention, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria Women may be eligible for this study if they: - Are HIV-positive. - Have been pregnant for 14-28 weeks (are in your 1st or 2nd trimester). - Have a normal ultrasound exam when they are screened for the study. - Are able to drink 6 glasses of water a day throughout the study. - Are at least 13 years old (need consent of parent or guardian if under 18). Exclusion Criteria Women will not be eligible for this study if they: - Cannot take 3TC or ZDV. - Have an active opportunistic (HIV-associated) or bacterial infection at study entry. - Have chronic diarrhea. - Have epilepsy or cancer. - Are pregnant with more than 2 children (triplets, etc.) - Have risk factors for premature birth, or other problems with their pregnancy. - Have any immediate life-threatening illness. - Have severe anemia or other illness for which they require blood products. - Have a history of chronic liver or kidney disease. - Plan to breast-feed.
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
DianaWara, Study Chair,
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Additional Information:
Study ID Numbers: ACTG 358; PACTG 358
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000944
Other Pregnancy Studies:
1. A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS
2. A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
3. 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
4. Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients
5. A Collection of Data from Adult AIDS Clinical Trials
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A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants
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