Effects of Therapeutic HIV Vaccination on Control of HIV After Discontinuation of Anti-HIV Drugs

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00050063

Collaborator

(none)

Enrollment

Locations

5.6

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether therapeutic HIV vaccines can help the immune system control HIV viral load after anti-HIV drugs are discontinued.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: Therapeutic vaccinations from A5058s

Detailed Description

This study is a rollover study for patients who participated in A5058s: Augmentation of HIV-Specific Helper and CTL Responses Through Therapeutic Vaccination in Individuals Receiving Potent Suppressive Antiretroviral Therapies. In A5058s, patients received a series of therapeutic vaccinations to elicit HIV-specific immune responses. This study will examine whether these vaccine-induced responses can control viral load in the absence of antiretroviral therapy (ART).

Upon study entry, patients will discontinue ART. During the first 6 weeks of the study, viral load will be monitored weekly and CD4+ T-cell counts will be monitored every other week. Viral load and CD4+ T-cell counts will be measured every other week from Week 6 through Week 24, then monthly until patients restart ART or until Week 48. Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 10 weeks.

Study Design

Study Type:

Observational

Time Perspective:

Prospective

Official Title:

A Rollover Study of A5058s: A Phase II Trial to Evaluate the Ability of Vaccine-Induced Helper and CTL Responses to Control Viremia in the Absence of Antiretroviral Therapy

Actual Study Completion Date :

May 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participation in A5058s and receipt of a minimum of 7 sets of injections on that study
Continuation of the same stable antiretroviral treatment that was given in A5058s for the last 3 months prior to A5172 entry, unless the regimen was changed for toxicity in the absence of virologic failure
No less than 6 weeks and no more than 18 weeks since the last injection on A5058s prior to A5172 entry
CD4+ T-cell count > 300 cells/mm3 obtained within 30 days prior to study entry
HIV-1 RNA < 500 copies/ml obtained within 30 days prior to study entry
Agreement to use approved methods of contraception

Exclusion Criteria:

Pregnancy or breast-feeding
Any of the following within 30 days prior to entry: acute infection requiring antibiotics, outbreak of herpes simplex virus (HSV) or herpes zoster, other acute medical illness, or surgery
Symptomatic chronic infections other than HIV
Malignancy that may require systemic therapy
History of lymph node irradiation
Use of immunoenhancing or immunosuppressive drugs within 30 days prior to entry, or any underlying disease of sufficient severity that these excluded drugs may be prescribed
Hydroxyurea within 30 days prior to study entry
Use of GM-CSF, G-CSF, M-CSF, IFN, IL-2, or other cytokines within 30 days prior to study entry
Active drug or alcohol use or dependence that would interfere with adherence to study requirements
Serious illness requiring systemic treatment and/or hospitalization until patient either completes therapy or is clinically stable on therapy for at least 30 days prior to study entry

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harbor-UCLA Med. Ctr. CRS	Torrance	California	United States	90502-2052
2	University of Colorado Hospital CRS	Aurora	Colorado	United States	80262
3	Indiana Univ. School of Medicine, Infectious Disease Research Clinic	Indianapolis	Indiana	United States	46202
4	Indiana Univ. School of Medicine, Wishard Memorial	Indianapolis	Indiana	United States	46202
5	Methodist Hosp. of Indiana	Indianapolis	Indiana	United States	46202
6	Massachusetts General Hospital ACTG CRS	Boston	Massachusetts	United States	02114
7	Bmc Actg Crs	Boston	Massachusetts	United States	02118
8	Beth Israel Deaconess Med. Ctr., ACTG CRS	Boston	Massachusetts	United States	02215
9	Brigham and Women's Hosp. ACTG CRS	Boston	Massachusetts	United States	02215
10	Beth Israel Med. Ctr., ACTU	New York	New York	United States	10003
11	NY Univ. HIV/AIDS CRS	New York	New York	United States	10016-6481
12	Unc Aids Crs	Chapel Hill	North Carolina	United States	27514
13	Case CRS	Cleveland	Ohio	United States	44106-5083
14	Univ. of Texas Medical Branch, ACTU	Galveston	Texas	United States	77555