Vaccine Therapy, Incomplete Freund's Adjuvant, and GM-CSF in Treating Patients With HIV

NCT00381875 | Completed Phase 1

• 5 other identifiers: 06021106-C-0211NCI-P6066NCI-6958CDR0000495768
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response. Incomplete Freund's adjuvant may stimulate the immune system in different ways and may help the vaccine work better. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with incomplete Freund's adjuvant and GM-CSF may be an effective treatment for patients with HIV. PURPOSE: This clinical trial is studying how well giving vaccine therapy together with incomplete Freund's adjuvant and GM-CSF works in treating patients with HIV.

Conditions

Nonneoplastic Condition

Keywords

HIV infection

Outcome Measures

Primary Outcomes (1)

• Impact of treatment on immune response, in terms of the difference between cytotoxic T-lymphocyte effector frequency, as measured by enzyme-linked immunospot (ELISPOT) at baseline and at week 20

Secondary Outcomes (3)

• Effects of treatment on viral load

• Sequencing of any resultant HIV strains

• CD4 counts for assessment of effects on HIV disease

Interventions

E1M184V peptide vaccine BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

sargramostim BIOLOGICAL

immunoenzyme technique OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * HIV-1 infection confirmed by Western blot and enzyme-linked immunosorbent assay * HLA-A2 positive by polymerase chain reaction-sequence specific primers * CD4 T-cell count ≥ 300/mm³ * Must be receiving stable regimen of highly active antiretroviral therapy (HAART) that does not include lamivudine or emtricitabine for ≥ 1 month prior to study entry * Patients on HAART, including lamivudine or emtricitabine, for which there is a medically appropriate regimen that does not include lamivudine or emtricitabine, are eligible if willing to change antiretrovirals * Viral load \< 50 copies/mL for 1 month prior to study entry PATIENT CHARACTERISTICS: * See Disease Characteristics * ECOG performance status 0-1 * Life expectancy ≥ 6 months * Hemoglobin ≥ 9 g/dL * WBC ≥ 1,000/mm³ * Absolute neutrophil count ≥ 750/mm³ * Platelet count ≥ 75,000/mm³ * PT and PTT ≤ 120% of control unless lupus anticoagulant detected * Bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 7.5 mg/dL with direct fraction ≤ 0.7 mg/dL if on protease inhibitor therapy or due to Gilbert's syndrome) * AST and ALT ≤ 2.5 times ULN * Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No hepatitis B surface antigen (HBsAg) or a prior history of HBsAg while on lamivudine or emtricitabine * Prior treatment with tenofovir and currently HBsAg negative allowed * No evidence of a severe or life-threatening infection other than HIV within the past 6 months * No opportunistic infections requiring systemic therapy within the past month * No active malignancy, except for basal cell carcinoma * No known hypersensitivity to incomplete Freund's adjuvant or incomplete Freund's adjuvant VG (vegetable-grade), E1M184V peptide, or sargramostim (GM-CSF) * No other abnormality that would be scored as ≥ grade 3 toxicity, except any of the following (if asymptomatic): * Hyperuricemia of grade 4 (without physiologic consequences) * Elevation of lactate dehydrogenase ≥ grade 3 * Elevation of creatine phosphokinase (CPK) ≥ grade 3 * Hypophosphatemia ≥ grade 3 (if patient is on tenofovir) * Elevation of alkaline phosphate of grade 3 * Hyperamylasemia of ≥ grade 3 allowed if any of the following criteria are met: * Macroamylasemia * Lipase ≤ 2 times ULN * Lymphopenia grade 3 * No other condition that, in the opinion of the investigator, would preclude compliance with study requirements PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No systemic corticosteroids within the past 3 weeks * Concurrent systemic corticosteroids allowed in the short term only * Physiologic replacement doses of steroids allowed * No prior vaccination with a vaccine that includes all or part of the reverse transcriptase of HIV-1 * No other concurrent investigational drugs or vaccinations * No concurrent lamivudine or emtricitabine

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

incomplete Freund's adjuvant; sargramostim; Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoassay; Immunologic Techniques; Investigative Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Kathleen M. Wyvill, BSN, RN

  NCI - HIV and AIDS Malignancy Branch

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 28, 2006
• Study Start: July 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: May 2, 2012

Record last verified: 2012-05

Locations

US (1)