NCT00125099

Brief Summary

The purpose of this study is to evaluate whether the HIV vaccine VRC-HIVDNA009-00-VP will be safe in individuals who started antiretroviral therapy during acute HIV-1 infection. The study will also test whether the vaccine can increase the immune system function in these participants.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

July 27, 2005

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Acute InfectionTreatment ExperiencedTreatment InterruptionHIV Therapeutic Vaccine

Outcome Measures

Primary Outcomes (4)

  • Grade 3 or 4 sign/symptom, laboratory abnormality, or death that may be related to the vaccine

  • 2 consecutive viral loads of 400 copies/ml or more while receiving HAART

  • 2 consecutive absolute CD4 cell counts of 250 cells/mm3 or more while receiving HAART

  • 2 consecutive CD4 cell counts more than 50% below the baseline CD4 cell count

Secondary Outcomes (4)

  • Tolerability (receipt of the full schedule of 4 vaccines)

  • viral load setpoint: average of the log10 viral load measures at Weeks 18, 20, and 22 after HAART withdrawl (study Weeks 48, 50, and 52)

  • Positive vaccine-elicited ELISPOT response as defined by a twofold increase from baseline that is also 100 or more spots/1,000,000 PBMCs

  • Positive vaccine-elicited intracellular cytokine staining response as defined by a twofold increase from baseline AND 300 or more spots/1,000,000 PBMCs

Interventions

VRC-HIVDNA009-00-VPBIOLOGICAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Treated acute HIV-1 infection (initiated HAART during the acute retroviral syndrome AND were diagnosed by a positive HIV-1 viral load and a negative or indeterminate Western blot)
  • Minimum of 6 months of HAART, defined as 2 or more antiretroviral drugs in combination
  • At least three CD4 cell counts over 350 cells/mm3 for a period of 6 months prior to study entry
  • Screening CD4 cell count over 350 cells/mm3 within 30 days prior to study entry
  • HIV-1 RNA levels over 50 copies/ml for a period of 6 months prior to study entry
  • Screening HIV-1 RNA level less than 50 copies/ml within 30 days prior to study entry
  • Agrees to use acceptable methods of contraception

You may not qualify if:

  • History of serious adverse reactions to vaccines
  • History of CD4 cell count less than 250 cells/mm3, opportunistic infections, or AIDS-defining illnesses. Patients who have had one CD4 count less than 250 cells/mm3 or who have had CD4 counts less than 250 cells/mm3 for not more than 2 weeks during acute infection are not excluded.
  • History of autoimmune disease, immunodeficiency, asthma, diabetes requiring insulin or oral hypoglycemics, thyroid disease, bleeding disorder, active malignancy, viral hepatitis, or asplenia
  • Positive HBV, HCV, or syphilis test
  • Suspected allergy or adverse reaction to any component of the study agent
  • Changes in antiretroviral regimen within 6 months prior to entry due to virologic failure (not including toxicities)
  • Previous participation in STIs
  • Pregnancy or breast-feeding
  • Live attenuated vaccines or investigational research agents within the 30 days prior to study entry
  • Blood products within the 120 days prior to study entry
  • Immunoglobulin within the 60 days prior to study entry
  • Subunit or killed vaccines or allergy treatments with antigen injections within the 14 days prior to study entry
  • Prior experimental HIV vaccines
  • Certain immunosuppressive medications within the 6 months prior to study entry
  • Current TB prophylaxis or therapy
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Ucsd, Avrc Crs

San Diego, California, 92103, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hosp. ACTG CRS

Boston, Massachusetts, 02115, United States

Location

Aaron Diamond AIDS Research Ctr. AIEDRP

New York, New York, 10021, United States

Location

UW Primary Infection Clinic CRS

Seattle, Washington, 98104, United States

Location

Related Publications (3)

  • Altfeld M, Rosenberg ES, Shankarappa R, Mukherjee JS, Hecht FM, Eldridge RL, Addo MM, Poon SH, Phillips MN, Robbins GK, Sax PE, Boswell S, Kahn JO, Brander C, Goulder PJ, Levy JA, Mullins JI, Walker BD. Cellular immune responses and viral diversity in individuals treated during acute and early HIV-1 infection. J Exp Med. 2001 Jan 15;193(2):169-80. doi: 10.1084/jem.193.2.169.

    PMID: 11148221BACKGROUND

  • Rosenberg ES, Altfeld M, Poon SH, Phillips MN, Wilkes BM, Eldridge RL, Robbins GK, D'Aquila RT, Goulder PJ, Walker BD. Immune control of HIV-1 after early treatment of acute infection. Nature. 2000 Sep 28;407(6803):523-6. doi: 10.1038/35035103.

    PMID: 11029005BACKGROUND

  • Rosenberg ES, Graham BS, Chan ES, Bosch RJ, Stocker V, Maenza J, Markowitz M, Little S, Sax PE, Collier AC, Nabel G, Saindon S, Flynn T, Kuritzkes D, Barouch DH; AIDS Clinical Trials Group A5187 Team. Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. PLoS One. 2010 May 10;5(5):e10555. doi: 10.1371/journal.pone.0010555.

    PMID: 20479938RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Dan H. Barouch, MD, PhD

    Beth Israel Deaconess Medical Center, Division of Viral Pathogenesis

    STUDY CHAIR

  • Eric S. Rosenberg, MD

    Massachusetts General Hospital, Division of Infectious Diseases

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 27, 2005

First Posted

July 29, 2005

Study Completion

September 1, 2007

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(5)