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| Name | Class |
|---|---|
| Rational Vaccines Inc | INDUSTRY |
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This study is an observational, cohort, prospective study looking at the frequency of Herpes Simplex Virus (HSV) 1 and or 2 outbreaks in HIV positive patients who's HIV virus is controlled on highly active anti-retroviral therapy. We will be enrolling fifty (50) patients.
We will be confirming that the patients are HIV positive and has antibodies to either HSV 1 or HSV 2 as part of the screening process. If so, we will then obtain patient baseline HIV-PCR, CD4, medial history including medications on day one. Whether the patient is on any or no herpes controlling medication. If the patient has what they feel is a flare up of HSV, they will come into clinic where the lesion will be culture and the patient's HIV-PCR and CD4 will also be obtained. Otherwise, the patient will receive phone follow ups every three months to see if there has been and change in their health or medications. The main endpoint is to see if there is a correlation between outbreaks in HIV patients and their CD4 cells and/or HIV and/or Herpes medication.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw | Other | We will be drawing blood for verify HIV status, HSV 1 or 2 antibodies, CD4 and HIV-PCR |
| Measure | Description | Time Frame |
|---|---|---|
| Epidemiology | The frequency of HSV outbreaks in HIV positive patients. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Co Morbidity | Correlation of HSV outbreak with patient CD4 count and/or HIV-PCR | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are positive for HIV antibodies and IgG or IgM antibodies to Herpes Simplex Virus 1 or Herpes Simplex Virus 2
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge E Rodriguez, M.D. | Contact | (323) 934-3690 | 4 | 2jrodmd@gmail.com |
| Michael S Gottlieb, M.D. | Contact | (323) 215-1725 | drmichael.gottlieb@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Research Institute | Recruiting | Los Angeles | California | 90036 | United States |
Share with Rational Vaccine
At conclusion of the study
Total Access
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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We are retaining patient serum
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |