Clinical trial NCT00000779: A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
Official title: A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Vaccines, Synthetic
HIV-1
Adjuvants, Immunologic
AIDS-Related Complex
HIV Envelope Protein gp120
AIDS Vaccines
HIV Therapeutic Vaccine
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 130
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3.

SECONDARY: To determine whether significant advantages to any one vaccine exist.

Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.

Detailed description: Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.

Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Short-term nonsteroidal anti-inflammatory therapy.

Patients must have:

* HIV seropositivity.
* CD4 count \>= 500 cells/mm3.
* Successful establishment of EBV-transformed B-cell lines at study entry.
* Consent of parent or guardian if \< 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Suspected or known allergies to any vaccine components.
* Medical contraindication.
* Problem with compliance.

Concurrent Medication:

Excluded:

* Antiretroviral therapy (e.g., AZT, ddI, or ddC).
* Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin).
* Parenteral therapies (including SC allergy sensitization).
* Other investigational HIV drugs or therapies.

Prior Medication:

Excluded:

* Any prior vaccinations against HIV.
* Antiretroviral therapy (e.g., AZT, ddI, or ddC) within the past 6 months.
* Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin) within the past 3 months.
* Parenteral therapies (including SC allergy sensitization) within the past 3 months.
* Other investigational HIV drugs or therapies within the past 3 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA CARE Center CRS
state: California
city: Palo Alto
country: United States
facility: Stanford CRS
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Med. Ctr.
state: California
city: San Mateo
country: United States
facility: San Mateo County AIDS Program
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital CRS
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital ACTG CRS
state: Massachusetts
city: Boston
country: United States
facility: Bmc Actg Crs
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Med. Ctr., ACTG CRS
state: Massachusetts
city: New York
country: United States
facility: NY Univ. HIV/AIDS CRS
state: New York
city: Seattle
country: United States
facility: University of Washington AIDS CRS
state: Washington
Study officials:
name: Schooley RT
role: STUDY_CHAIR
name: Walker B
role: STUDY_CHAIR
References:
citation: Schooley RT, Spino C, Chiu S, DeGruttola V, Kuritzkes DR. Poor immunogenicity of HIV-1 envelope vaccines with alum or MF59 aduvant in HIV-infected individuals: results of two randomized trials. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:204 (abstract no 756)
citation: Schooley RT, Spino C, Kuritzkes D, Walker BD, Valentine FA, Hirsch MS, Cooney E, Friedland G, Kundu S, Merigan TC Jr, McElrath MJ, Collier A, Plaeger S, Mitsuyasu R, Kahn J, Haslett P, Uherova P, deGruttola V, Chiu S, Zhang B, Jones G, Bell D, Ketter N, Twadell T, Chernoff D, Rosandich M. Two double-blinded, randomized, comparative trials of 4 human immunodeficiency virus type 1 (HIV-1) envelope vaccines in HIV-1-infected individuals across a spectrum of disease severity: AIDS Clinical Trials Groups 209 and 214. J Infect Dis. 2000 Nov;182(5):1357-64. doi: 10.1086/315860. Epub 2000 Oct 9.