A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3 - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

July 29, 2008

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 NCT00000755 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3

Official Title ^ICMJE

A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3

Brief Summary

To examine the response of HIV-1 infected patients to vaccination with gp120/HIV-1MN antigen. To determine the effect of antiretroviral therapy on vaccine responsiveness.

Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens.

Detailed Description

Patients are randomized to receive rgp120/HIV-1MN vaccine or alum adjuvant placebo by intramuscular injection at weeks 0, 4, 8, 12, 16, and 20, with or without daily oral zidovudine (AZT) or their current stable dose of antiretroviral therapy. After completing the primary vaccination series, patients are permitted to continue into an extension phase, in which they receive a booster vaccination at weeks 28, 36, and 44. Patients will be stratified by CD4 count: 350-500, 200-349, and 50-199 cells/mm3. A fourth group with counts of 350-500 cells/mm3 will serve as a pilot group and receive vaccine only.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Parallel Assignment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Biological: rgp120/HIV-1MN
Drug: Zidovudine

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

168

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria

Required immediately prior to study entry:

A minimum of 2 and a maximum of 12 months of AZT therapy at 500-600 mg/day (does not apply to the pilot group patients receiving vaccine only and to patients with CD4 counts of 50-199 cells/mm3).

Concurrent Medication:

Allowed:

PCP prophylaxis.
Rifabutin and clarithromycin (in patients with CD4 counts of 50-199 cells/mm3 only).
Short-term nonsteroidal anti-inflammatory therapy for acute conditions.
Short intermittent cycles of acyclovir.

Patients must have:

HIV infection, with CD4 count of 50-500 cells/mm3.
No active opportunistic infection (patients with CD4 counts of 50-199 cells/mm3 may have a history of an opportunistic infection).
Consent of parent, guardian, or person with power of attorney, if less than 18 years of age.
B-cell lines established in order to be vaccinated.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Known or suspected allergies to any vaccine components.

Concurrent Medication:

Excluded:

Agents with immunosuppressive activity.
Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-199 cells/mm3).
Interferon.
Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma).
Steroids.
Hematopoietins.

Prior Medication:

Excluded within 12 weeks prior to study entry:

Agents with immunosuppressive activity.
Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-349 cells/mm3).
Interferon.
Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma).
Steroids.
Hematopoietins.

Active drug abuse.

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

NCT00000755

Responsible Party

Study ID Numbers ^ICMJE

ACTG 209

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Genentech
Glaxo Wellcome

Investigators ^ICMJE

Study Chair:	Schooley RT
Study Chair:	Walker B

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

March 2003

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