A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Vaccines, Synthetic, HIV Envelope Protein gp160, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Recommended: PCP prophylaxis. Patients must have: Documented asymptomatic HIV infection. CD4+ count as follows: 1-11 months of age must have > 2000 cells/mm3 and >= 30 percent of the total lymphocytes; 12-23 months must have > 1000 cells/mm3 and >= 20 percent of the total lymphocytes; 24 months-6 years must have > 750 cells/mm3 and >= 20 percent of the total lymphocytes; and 7 years and older must have > 500 cells/mm3 and >= 20 percent of the total lymphocytes. NOTE: Patients who received zidovudine for 3 consecutive months immediately prior to study entry may receive only high doses of vaccine. Exclusion Criteria Co-existing Condition: Patients with the following condition are excluded: Any serious acute infection. Concurrent Medication: Excluded: Anticipated steroid therapy of > 6 weeks duration. Excluded within the past 2 years: More than one serious proven bacterial infection such as sepsis, pneumonia, meningitis, bone or joint infection, abscess of an internal organ or body cavity (other than otitis media or superficial skin or mucosal abscesses) caused by Haemophilus, Streptococcus, Pneumococcus, or other pyogenic bacteria. Prior Medication: Excluded: Antiretroviral therapy or immunomodulators (e.g., IVIG) within 1 month prior to study entry (NOTE: AZT is allowed within 1 month prior to study entry if patient is entering a high-dose arm). Uninterrupted steroid therapy of > 6 weeks duration.
Sites / Locations
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
- Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
- San Francisco Gen. Hosp.
- UCSF Pediatric AIDS CRS
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
- Univ. of Connecticut Health Ctr., Dept. of Ped.
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
- Cook County Hosp.
- Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
- Chicago Children's CRS
- Tulane/LSU Maternal/Child CRS
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- BMC, Div. of Ped Infectious Diseases
- Baystate Health, Baystate Med. Ctr.
- WNE Maternal Pediatric Adolescent AIDS CRS
- UMDNJ - Robert Wood Johnson
- NJ Med. School CRS
- St. Joseph's Hosp. & Med. Ctr. of New Jersey
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
- North Shore-Long Island Jewish Health System, Dept. of Peds.
- NYU Med. Ctr., Dept. of Medicine
- Columbia IMPAACT CRS
- Incarnation Children's Ctr.
- Univ. of Rochester ACTG CRS
- SUNY Upstate Med. Univ., Dept. of Peds.
- DUMC Ped. CRS
- The Children's Hosp. of Philadelphia IMPAACT CRS
- St. Christopher's Hosp. for Children
- Texas Children's Hosp. CRS
- San Juan City Hosp. PR NICHD CRS