|
A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) 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 Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants Clinical research trials and A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants health trials take place in a lot of of cities across the US. 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 / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants. A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants  A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) 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 evaluate the safety and tolerance of 2 anti-HIV drugs, d4T and 3TC, given in combination to HIV-positive pregnant women and their infants. Most HIV-positive pregnant women usually take the anti-HIV drug zidovudine (ZDV) to treat HIV and reduce the chances of giving HIV to their babies. It recently has been shown that a combination of drugs may be more effective than ZDV alone. This study tests the effectiveness of combinations of ZDV, d4T, and 3TC.
Details: New antiretroviral agents or combinations are sought that are as efficacious as ZDV and that would be effective in reducing the rate of vertical transmission of HIV in women who have been long-term recipients of ZDV. d4T is a good candidate drug. It is a thymidine nucleoside analogue that inhibits replication of HIV at concentrations similar to those of ZDV which have anti-HIV activity. The demonstrated safety profile of d4T, the ease of administration, and, most importantly, preliminary efficacy data, especially in combination with 3TC, make this an excellent candidate combination for a Phase I perinatal trial. Two cohorts of women and infants are enrolled in this study. The first five mother/infant pairs enrolled comprise Group I. Mothers enrolled in this group must allow their infants to receive ZDV. Eight mother/infant pairs are then enrolled in Group II; Group II infants are allocated into two groups: those whose mothers allow the administration of ZDV (Group IIA) and those whose mothers do not (Group IIB). Group I: Women: Beginning at a minimum of 14 weeks gestation: 1. Oral d4T until the start of active labor. 2. Oral 3TC. At the start of active labor (defined as regular uterine contractions resulting in cervical dilation [3-4 cm] and effacement [50-60%]) and during delivery: 1. d4T administered IV as a loading dose followed by a continuous infusion until the umbilical cord is clamped. 2. Oral 3TC if patient's previous dose of 3TC was administered at least 0.5h prior to onset of labor and additional dose of 3TC is administered and the time until next dose is scheduled accordingly. Infants: 1. d4T as a single oral dose on Day 6 (+/- 2 days) and on Day 42 (this dose can be given between Days 35 and 42, inclusive). 2. Oral ZDV (or IV if unable to take oral dosing) for 6 weeks, beginning a maximum of 12 hours after birth. 3. 3TC for 6 weeks, beginning a maximum of 12 hours after birth. Group II: Women: Beginning at a minimum of 14 weeks gestation: 1. Oral d4T until the umbilical cord is clamped. 2. Oral 3TC. At the start of active labor and through delivery: Oral d4T and 3TC as above. If the last doses of d4T and 3TC were given at least 0.5 hours prior to onset of active labor, an additional dose of d4T and 3TC is given and repeated every 12 hours. Infant Group IIA: 1. d4T as a single oral dose on Day 6 (+/- 2 days) and on Day 42 (this dose can be given between Days 35 and 42, inclusive). 2. Oral ZDV (or IV if unable to tolerate oral dosing) for 6 weeks, beginning a maximum of 12 hours after birth. 3. 3TC for 6 weeks, beginning a maximum of 12 hours after birth. Infant Group IIB: Beginning a maximum of 12 hours after birth: 1. d4T for 6 weeks. 2. 3TC for 6 weeks. [AS PER AMENDMENT 9/15/97: If tolerated, infants continue on protocol treatment to 6 weeks of age. At 6 weeks, infants should receive standard care, including PCP prophylaxis, from an HIV specialist/pediatrician. HIV-infected infants are offered ACTG trial enrollment or open-label treatment based on best clinical judgment of their physician.] [AS PER AMENDMENT 2/19/99: Patients who prematurely discontinue study treatment should continue to be followed on study for the duration of the study.]
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Women may be eligible for this study if they: - Are HIV-positive. - Are at least 13 years old (need consent of parent or guardian if under 18). - Are unable to or refuse to take ZDV or the woman's doctor says that she should take d4T. - Are 14 to 34 weeks pregnant. Exclusion Criteria Women will not be eligible for this study if they: - Have a history of peripheral neuropathy. - Have an active opportunistic infection and/or serious bacterial infection within 14 days of study entry. - Have severe diarrhea. - Are allergic to d4T or 3TC. - Use illicit drugs or abuse alcohol. - Are taking anti-HIV drugs other than study medications. - Are planning to breast-feed. - Are having a problem pregnancy (baby is not developing correctly or will not survive birth) or have had pregnancy complications in the past. - Babies will not be eligible for this study if they: - Are unable to take medications by mouth for more than 72 hours. - Have severe birth defects or other life-threatening conditions. - Are underweight (less than 2 kg).
Total Enrollment: 26
Location and Contact Information:
Overall Study Official:
NancyWade, Study Chair,
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Temple Univ School of Medicine
Philadelphia, Pennsylvania, 191341095
United States
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Additional Information:
Study ID Numbers: ACTG 332; PACTG 332
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000878
Other Hiv Infections Studies:
1. A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies
2. Effectiveness of BufferGel as a Vaginal Contraceptive
3. Prenatal Screening For Smith-Lemli-Opitz Syndrome
4. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants
5. Effect of Pregnancy on Uveitis
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
|
|
|
|
|
|
|
|
