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

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

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.

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.

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