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Home > "A" Clinical Trials Conditions > Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)  Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
For Condition: HIV Infections,Pregnancy,HIV Seronegativity
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: PRIMARY: To evaluate the short-term safety of rgp120/HIV-1SF2 vaccine versus MF59 placebo administered to HIV-infected pregnant women. SECONDARY: To evaluate the immunogenicity and long-term safety of rgp120/HIV-1SF2 in HIV-infected pregnant women who received the vaccine during pregnancy only or during pregnancy and postpartum. To evaluate immunogenicity and safety in the infant through 18 months of age following maternal immunization with the vaccine during pregnancy. Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of epitope-specific antibody. Also, active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers.
Details: Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of epitope-specific antibody. Also, active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers. Women are randomized to receive rgp120/HIV-1SF2 vaccine or MF59 placebo. Patients receive the first immunization between 16 and 24 weeks gestation and monthly thereafter until delivery, for a maximum of five immunizations. Patients may continue to receive the immunization regimen to which they were originally assigned at 3, 6, 9, and 12 months postpartum. Maternal follow-up continues until 18 months postpartum; infants are followed until age 18 months.
Eligibility:
Study Type: Interventional, Prevention, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 16 Years/40 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed during pregnancy: - AZT. - Methadone maintenance. NOTE: - Patients may not initiate antiretroviral therapy for disease progression. NOTE: - Patients may change from AZT to another antiretroviral agent or may begin antiretroviral therapy following delivery, if clinically indicated. Patients must have: - Documented HIV infection. - CD4 count >= 400 cells/mm3 (average of two determinations obtained 1 week apart). - No clinical criteria for a diagnosis of AIDS. - HIV p24 antigen <= 30 pg/ml. - Estimated gestational age between 16 and 24 weeks, confirmed by baseline sonogram that does not demonstrate any congenital abnormalities considered to be incompatible with life. - Intention to carry pregnancy to term. - Willingness to be followed by an ACTU for the duration of the study. NOTE: - Father of the fetus (if available after a reasonable attempt to contact him) must provide informed consent. Prior Medication: Allowed: - AZT. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Known hypersensitivity to a component of the vaccine. - Hepatitis B antigen positive at study entry. - Evidence of life-threatening or other serious pre-existing fetal abnormalities (e.g., anencephaly, renal agenesis, Potter's syndrome). - Evidence of syphilis that requires therapy during this pregnancy. - Intention to breast-feed. Presence of obstetrical high-risk factors such as: - insulin-dependent diabetes - hypertension requiring the use of anti-hypertensive therapy - repeated intrauterine fetal demise - Rh-sensitization or other blood group alloimmunization - diseases requiring use of immunosuppressive therapy (e.g., asthma, lupus). Concurrent Medication: Excluded during pregnancy: - Antiretrovirals other than AZT. - Immunomodulating agents (e.g., HIVIG, IVIG). - Other investigational drugs or immunosuppressive agents. NOTE: - Patients may change from AZT to another antiretroviral agent or may begin antiretroviral therapy following delivery, if clinically indicated. Prior Medication: Excluded within 90 days prior to study entry: - Antiretrovirals other than AZT. - Immunomodulating agents (e.g., HIVIG, IVIG). Current use of illicit drugs or chronic alcohol use by patient history.
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
StarrS, Study Chair,
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
UMDNJ - New Jersy Med Schl / Children's Hosp of Newark
Newark, New Jersey, 07107
United States
Additional Information:
Study ID Numbers: ACTG 233;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001046
Other Hiv Seronegativity Studies:
1. Ultrasound and motivational enhancement for prenatal smoking cessation
2. Providing Birth Control Through Home Health Visits
3. Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (NOTE: Some Patients Receive Placebo)
4. Studying Fetal Breathing Patterns
5. A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women
Related Studies:
Other HIV Seronegativity Clinical Trials
Other Massachusetts Clinical Trials
Other Springfield Clinical Trials
Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
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