A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
Public ClinicalTrials.gov record NCT00000774. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
PRIMARY: To determine the safety of envelope recombinant proteins rgp120/HIV-1MN (Genentech) and rgp120/HIV-1SF2 (Chiron/Biocine) in infants who are of indeterminate HIV status born to HIV-infected women. To evaluate changes in viral load in infants proven to be infected and absolute CD4 counts in all immunized infants. SECONDARY: To evaluate the immunogenicity of these envelope recombinant proteins in infants of indeterminate HIV status born to HIV-infected women. Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may enhance HIV-specific immune function to alter HIV replication and disease progression.
Study identification
- NCT ID
- NCT00000774
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 156 participants
Conditions and interventions
Conditions
Interventions
- rgp120/HIV-1MN Biological
- rgp120/HIV-1 SF-2 Biological
- Placebo version of rgp120/HIV-1MN Biological
- Placebo version of rgp120/HIV-1SF2 Biological
Biological
Eligibility (public fields only)
- Age range
- 1 Day to 3 Days
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Jan 1999 (Actual)
- Last update posted
- Nov 4, 2021
Ends 1999
United States locations
- U.S. sites
- 36
- U.S. states
- 14
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Long Beach Memorial Med. Ctr., Miller Children's Hosp. | Long Beach | California | 90801 | — |
| UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | Los Angeles | California | 900951752 | — |
| UCSD Maternal, Child, and Adolescent HIV CRS | San Diego | California | 920930672 | — |
| San Francisco Gen. Hosp. | San Francisco | California | 94110 | — |
| UCSF Pediatric AIDS CRS | San Francisco | California | 941430105 | — |
| Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases | Torrance | California | 905022004 | — |
| Univ. of Colorado Denver NICHD CRS | Aurora | Colorado | 802181088 | — |
| Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease | New Haven | Connecticut | 06504 | — |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | 32209 | — |
| Univ. of Miami Ped. Perinatal HIV/AIDS CRS | Miami | Florida | 33161 | — |
| Cook County Hosp. | Chicago | Illinois | 60612 | — |
| Chicago Children's CRS | Chicago | Illinois | 606143394 | — |
| Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease | Chicago | Illinois | 606371470 | — |
| Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic | New Orleans | Louisiana | 701122699 | — |
| Tulane/LSU Maternal/Child CRS | New Orleans | Louisiana | — | — |
| Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases | Baltimore | Maryland | 212874933 | — |
| Brigham and Women's Hosp., Div. of Infectious Disease | Boston | Massachusetts | 02115 | — |
| BMC, Div. of Ped Infectious Diseases | Boston | Massachusetts | 02118 | — |
| HMS - Children's Hosp. Boston, Div. of Infectious Diseases | Boston | Massachusetts | — | — |
| Baystate Health, Baystate Med. Ctr. | Springfield | Massachusetts | 01199 | — |
| NJ Med. School CRS | Newark | New Jersey | 07103 | — |
| St. Joseph's Hosp. & Med. Ctr. of New Jersey | Paterson | New Jersey | — | — |
| NYU Med. Ctr., Dept. of Medicine | New York | New York | 10016 | — |
| Columbia IMPAACT CRS | New York | New York | 10032 | — |
| Incarnation Children's Ctr. | New York | New York | 10032 | — |
| Strong Memorial Hospital Rochester NY NICHD CRS | Rochester | New York | 14642 | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | — | — |
| SUNY Stony Brook NICHD CRS | Stony Brook | New York | 117948111 | — |
| SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse | New York | 13210 | — |
| Bronx-Lebanon Hosp. IMPAACT CRS | The Bronx | New York | 10457 | — |
| WNE Maternal Pediatric Adolescent AIDS CRS | Worcester | New York | — | — |
| DUMC Ped. CRS | Durham | North Carolina | 277103499 | — |
| The Children's Hosp. of Philadelphia IMPAACT CRS | Philadelphia | Pennsylvania | 191044318 | — |
| Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Texas Children's Hosp. CRS | Houston | Texas | 77030 | — |
| UW School of Medicine - CHRMC | Seattle | Washington | 981050371 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000774, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 4, 2021 · Synced Nov 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000774 live on ClinicalTrials.gov.