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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
- Dec 31, 1998
- Last update posted
- Nov 3, 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 3, 2021 · Synced Sep 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00000774 live on ClinicalTrials.gov.