Phase I Study to Evaluate the Safety and Immunogenicity of HIV-1 Immunogen in Children With HIV-1 Infection

NCT00001445 | Completed Phase 1

• 2 other identifiers: 95017295-C-0172
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single dose, phase I study to evaluate the safety/tolerance and the immunogenicity of HIV-1 Immunogen, gp120-depleted inactivated HIV-1 preparation in Incomplete Freund's Adjuvant (IFA), in children with HIV-1 infection. A total of 32 children with HIV-1 infection will be enrolled in the study. Arm A of the study will enroll children who have no or moderate immune suppression at the time of study entry as defined by CDC classification and who have no history of and do not require antiretroviral therapy. Antiretroviral treatment given for less than 7 weeks (up to 6 weeks and 6 days) prior to entry will be considered as "no history" of treatment (treatment naive). Arm B will enroll children who have no or moderate immune suppression at the time of study entry as defined by CDC classification and who are on or have received antiretroviral treatment for more than 7 weeks. In order to assess the age-associated impact on the immune response rate, we plan to continue to attempt to enroll infants younger than 24 months of age. Children in each arm will receive 10 units of HIV-1 Immunogen intramuscularly at 0, 3, 6, 9, and 12 months. Antiretroviral treatment will commence once patients meet the criteria for an initiation of the treatment as defined in the protocol. All antiretroviral agents that are currently approved by FDA for clinical indications in HIV-1-infected children (pediatric labeling) are permitted in the protocol. If the child has been receiving a single agent other than ddI, or has been on investigational antiretroviral agents, his/her antiretroviral therapy will have to be changed to an optimal combination regimen of the approved agents at least 6 weeks prior to the enrollment.

Conditions

HIV Infection

Keywords

Adjuvant-Controlled Study; Double Blind Randomization; Env-Deleted Inactivated HIV-1; Therapeutic HIV Vaccine

Interventions

HIV-1 Immunogen BIOLOGICAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Each child enrolled in arm B has to be on constant regimen of antiretroviral treatment for at least 6 weeks-prior to the first inoculation. Children in immune categories 1 and 2 at the time of study entry will be allowed to enroll.
• Not critically ill or clinically unstable or no presence of active infection requiring on-going (or induction) therapy.
• No evidence of severe immune suppression at the time of study entry as defined by CDC classification system, Immune Category 3.
• For children younger than 24 months of age, no plasma HIV-1 RNA levels greater than or equal to 5 x 10(4) copies/ml despite appropriate antiretroviral treatment, confirmed at least at two different time points 2 to 4 weeks apart.
• No use of tube feeding or intravenous hyperalimentation itself will be allowed as long as it is a stable regimen.
• No administration of chemotherapeutic agents, or use of immunomodulating agents such as corticosteroids, interferons, G-CSF, EPO, growth hormone (GH) or IVIG within one month of enrollment.
• No abnormalities of laboratory findings within one month of enrollment including the following: SGPT or SGOT greater than 5 times the normal value; Total bilirubin greater than 3 times normal; BUN or creatinine greater than 2 times normal; Total WBC greater than 150/mm(3) or ANC greater than 750/mm(3); Hemoglobin greater than 8.0 g/dl (transfusions are allowed); Platelet count greater than 100,000/mm(3).
• Not pregnant or not planning to become pregnant.
• No active substance abuse.
• Able to comply with the study requirements for scheduled evaluations such as periodic clinic visits or blood sampling.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Robert-Guroff M, Brown M, Gallo RC. HTLV-III-neutralizing antibodies in patients with AIDS and AIDS-related complex. Nature. 1985 Jul 4-10;316(6023):72-4. doi: 10.1038/316072a0.

  PMID: 2989707 BACKGROUND

• Weiss RA, Clapham PR, Cheingsong-Popov R, Dalgleish AG, Carne CA, Weller IV, Tedder RS. Neutralization of human T-lymphotropic virus type III by sera of AIDS and AIDS-risk patients. Nature. 1985 Jul 4-10;316(6023):69-72. doi: 10.1038/316069a0.

  PMID: 2989706 BACKGROUND

• Allain JP, Laurian Y, Paul DA, Verroust F, Leuther M, Gazengel C, Senn D, Larrieu MJ, Bosser C. Long-term evaluation of HIV antigen and antibodies to p24 and gp41 in patients with hemophilia. Potential clinical importance. N Engl J Med. 1987 Oct 29;317(18):1114-21. doi: 10.1056/NEJM198710293171804.

  PMID: 3477695 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

HIV-1 immunogen, incomplete Freund's adjuvant

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: August 1, 1995
• Study Completion: July 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-08

Locations

US (1)