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Completed

NCT Number: NCT00659789

Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV

Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.

ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.

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Key information

Conditions

HIV I Infection

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charité Universitätsmedizin Berlin, Berlin, State of Berlin, Germany

Loading trial locations.

About this study

Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore,ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.

ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-55
  • HIV positive at least one year
  • Clinically stable on ART for at least six months
  • Documented viral load less than 50 copies/mL for the last six months
  • Documented prestudy CD4 cell count equal or more than 400x10exp6/L
  • Nadir CD4 cell count equal or more than 200x10exp6/L
  • Signed informed consent

Exclusion criteria

  • Reported pre-study AIDS-defining illness within the previous year
  • Malignant disease
  • On chronic treatment with immuno-suppressive therapy
  • Unacceptable values of hematology and clinical chemistry parameters
  • Current chronic infection such as HCV and HBV or active tuberculosis
  • Pregnant or breastfeeding women
  • Not using safe contraceptive methods
  • Participation in other clinical trial
  • Incapability of compliance

Treatment and study plan

Vacc-4x

Drug

Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

Other names: Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13.

Sterile water

Drug

Sterile water is used in place of Vacc-4x and in place of Leukine

Other names: Placebo

Primary outcomes

  1. Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.

    Time frame: From Week 28 to Week 52

Secondary outcomes

  1. Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths

    Time frame: Up to week 52

    Brief summary of treatment emergent adverse events or related treatment emergent events and deaths. The intensity of adverse events was described according to the Division of AIDS table for grading severity of adult and pediatric adverse events, 2004.

  2. Immunogenicity

    Time frame: Week 1, week 18 and week 52

    Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema

  3. Effect of Vacc-4x on CD8 Counts

    Time frame: Weeks 6,18,24,28,32,36,40,44,48,52.

    CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52

  4. Time to Restart of ART for Vacc-4x Subjects Versus Placebo

    Time frame: Between Week 28 to Week 52

    Kaplan-Meier Estimate of Time to restart ART (from time coming off ART)

  5. Effects on Vacc-4x on HIV-1 RNA

    Time frame: Weeks 24,28,32,36,40,44,48,52.

Sponsors and collaborators

Lead sponsor

Bionor Immuno AS

Industry

Registry information

Official study title

A Phase II, Randomized, Double-blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV-1 Who Have Maintained an Adequate Response to ART

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Apr 16, 2008
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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