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
HIV Infections

Further Study Details: 

Expected Total Enrollment:  78

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

California
      Harbor General/UCLA, Torrance,  California,  90502-2052,  United States
Colorado
      Univ of Colorado Health Sciences Ctr, Denver, Denver,  Colorado,  80262,  United States
Indiana
      Indiana Univ Hosp, Indianapolis,  Indiana,  46202,  United States
      Methodist Hosp of Indiana, Indianapolis,  Indiana,  46202,  United States
      Wishard Hosp, Indianapolis,  Indiana,  46202,  United States
Massachusetts
      Harvard (Massachusetts General Hosp), Boston,  Massachusetts,  02114,  United States
      Boston Med Ctr (Harvard), Boston,  Massachusetts,  02118,  United States
      Brigham and Womens Hosp, Boston,  Massachusetts,  02215,  United States
      Beth Israel Deaconess- West Campus, Boston,  Massachusetts,  02215,  United States
New York
      NYU/Bellevue, New York,  New York,  10016-6481,  United States
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
North Carolina
      Univ of North Carolina, Chapel Hill,  North Carolina,  27514,  United States
Ohio
      Case Western Reserve Univ, Cleveland,  Ohio,  44106-5083,  United States
Texas
      Univ of Texas, Galveston, Galveston,  Texas,  77555,  United States

Study chairs or principal investigators

Spyros Kalamus, M. D.,  Study Chair,  Vanderbilt University Medical Center   
Fred Valentine, M. D.,  Study Chair,  NYU Medical Center   

Study ID Numbers:  ACTG A5172
Record last reviewed:  November 2004
Last Updated:  April 7, 2005
Record first received:  November 20, 2002
ClinicalTrials.gov Identifier:  NCT00050063
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08