|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | GeneCure Biotechnologies |
|---|---|
| Information provided by (Responsible Party): | GeneCure Biotechnologies |
| ClinicalTrials.gov Identifier: | NCT01428596 |
Purpose
This study is to test a therapeutic HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects. The safety and immune responses will be studied in vaccine recipients. The anti-viral effect of HIVAX vaccine will be monitored during a 12-week treatment interruption phase.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: HIVAX Biological: saline solution Biological: Saline solution |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase I Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Replication-defective HIV-1 Vaccine (HIVAX™) in HIV-1 Infected Subjects Receiving Highly Active Antiretroviral Therapy |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Lower dose HIVAX vaccine
|
Biological: HIVAX
Vaccine 1.0 ml SQ lower dose (10^8 TU) at weeks 0, 8 and 16.
|
|
Placebo Comparator: Arm II
lower dose, placebo control
|
Biological: saline solution
Saline solution 1.0 ml SQ at weeks 0, 8 and 16.
|
|
Experimental: Arm III
Higher dose vaccine
|
Biological: HIVAX
Vaccine 1.0 ml SQ higher dose (10^9 TU) at weeks 0, 8 and 16.
|
|
Placebo Comparator: Arm IV
Higher dose, placebo control
|
Biological: Saline solution
saline solution 1.0 ml SQ at weeks 0, 8 and 16.
|
This is a randomized, placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of two doses of a replication defective HIV-1 vaccine (HIVAX™) in subjects receiving stable highly active antiretroviral therapy (HAART) who have an HIV-1 RNA <50 copies/ml and CD4 cell count >500 cells/mm3. Following the randomized placebo-controlled vaccination phase subjects who received active vaccine and who meet eligibility will undergo a 12-week analytical antiretroviral treatment interruption followed by reinstitution of antiretroviral therapy (or continued interruption) with follow up through week 48.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Part I (vaccination phase) Inclusion Criteria:
On highly active antiretroviral therapy defined as the combination of at least three antiretroviral agents for at least 12 months prior to study entry.
NOTE: A regimen that included only the combination of 3 NRTIs alone will not meet the study definition of a highly active antiretroviral therapy regimen. The combination of low dose ritonavir and another PI will be considered as one antiretroviral agent. Subjects cannot be on an NNRTI containing regimen at study entry.
Subjects must be on a stable regimen (no change in therapy) for at least 2 months prior to study entry.
NOTE: A change in formulation or class for reasons other than virologic failure will be allowed but must have documented viral suppression (HIV RNA <50 copies/ml) on at least two consecutive measurements at least two weeks apart.
Prior sustained response to antiretroviral therapy defined as an HIV-1 RNA <50 copies/ml and a CD4 cell count >500 cells/mm3 for twelve months prior to study entry documented on at least three measurements prior to study entry.
NOTE: cannot have any confirmed HIV-1 RNA ≥50 copies/ml during the 12-months prior to study entry.
Laboratory values obtained within 30 days prior to study entry.
Willingness to use adequate contraception by study participants
Subjects must agree not to participate in a conception process (e.g., active attempts to become pregnant or to impregnate, sperm donation, or in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, subjects must use a form of contraception as listed below while on study vaccine and for 60 days after stopping study vaccine.
Women without reproductive potential (i.e., have reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation) or women whose male partner has undergone successful vasectomy with documented azoospermia or has documented azoospermia for any other reason, are eligible without requiring the use of contraception.
NOTE: Subject-reported history is acceptable documentation of sterilization (hysterectomy, bilateral oophorectomy, tubal ligation, or vasectomy).
As appropriate, at least one of the following methods must be used appropriately with or without a hormonal-based method during the study:
Part I (vaccination phase) Exclusion Criteria:
Investigational agents and immunomodulators (cyclosporine, hematological growth factors, systemic corticosteroids, interleukins or interferons) within 90 days prior to study entry.
NOTE: Subjects may be on antiretroviral agents not yet approved by the FDA as part of a clinical trial or expanded access program.
Part II (treatment interruption phase) Inclusion Criteria (Arm I and III only):
Receipt of three vaccinations . At the completion of the first 24 weeks of the study, potential eligible subjects for Part II will be unblinded, as to the receipt of active vaccine.
NOTE: Subjects in Arm II and IV (vaccine placebo recipients) participation in the study will end with Part I.
Part II Exclusion Criteria:
Contacts and Locations| Contact: Margaret A. Fischl, MD | 305-243-3847 | mfischl@med.miami.edu |
| United States, Florida | |
| University of Miami School of Medicine, AIDS Clinical Research unit | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Lillian Colon, RN,BSN 305-243-3838 lcolon2@med.miami.edu | |
| Principal Investigator: Margaret A. Fischl, MD | |
| Study Director: | Margaret Fischl, MD | University of Miami |
More Information
| Responsible Party: | GeneCure Biotechnologies |
| ClinicalTrials.gov Identifier: | NCT01428596 History of Changes |
| Other Study ID Numbers: | A010 |
| Study First Received: | September 1, 2011 |
| Last Updated: | September 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 therapeutic vaccine immunotherapy AIDS |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |