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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by (Responsible Party): | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01218113 |
Purpose
This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the initiation of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Human Immunodeficiency Virus Type 1(HIV-1) Infection Infection, Human Immunodeficiency Virus Antiretroviral Therapy (ART)-naïve Adults |
Biological: GSK Biologicals HIV Vaccine 732462 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of HIV Vaccine 732462 in ART-naïve HIV-1 Infected Persons |
| Estimated Enrollment: | 189 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group A |
Biological: GSK Biologicals HIV Vaccine 732462
2 or 3 doses according to protocol schedule
|
| Experimental: Group B |
Biological: GSK Biologicals HIV Vaccine 732462
2 or 3 doses according to protocol schedule
Drug: Placebo
1 or 3 doses according to protocol schedule
|
| Placebo Comparator: Group C |
Drug: Placebo
1 or 3 doses according to protocol schedule
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal. Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
The following criteria should be checked at the time of screening and before vaccination. If ANY exclusion criterion applies, the subject must not be included in the study:
Planned administration of a vaccine not foreseen by the study protocol during
Contacts and Locations
Show 39 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01218113 History of Changes |
| Other Study ID Numbers: | 111679 |
| Study First Received: | October 7, 2010 |
| Last Updated: | May 17, 2012 |
| Health Authority: | Germany: Paul-Ehrlich Institute Spain: Agencia Espanola de Medicamentos y Productos Sanitarios France: Afssaps - French Health Products Safety Agency United States: Food and Drug Administration |
|
Human Immunodeficiency Virus (HIV)-1 safety vaccine |
immunogenicity reactogenicity HIV infection |
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Virus Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |