Status:
WITHDRAWN
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)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Pregnancy
Eligibility:
FEMALE
16-40 years
Phase:
PHASE1
Brief Summary
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 o...
Detailed Description
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 antibo...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00001046
Last Update
November 1 2021
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