A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3 - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000779 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3

Official Title ^ICMJE

A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Safety Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Biological: Aluminum hydroxide
Biological: MF59
Biological: rgp120/HIV-1IIIB
Biological: rgp120/HIV-1MN
Biological: rgp120/HIV-1 SF-2
Biological: Env 2-3

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

130

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

13 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000779

Responsible Party

Study ID Numbers ^ICMJE

ACTG 214

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	Schooley RT
Study Chair:	Walker B

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

October 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP