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The main purpose of this study is to learn whether the study vaccine and the adjuvants(drugs that are used to help immune response) have an acceptable safety profile in treating individuals with HIV.
A second purpose for this study is to understand how your immune system responds to the study vaccine with the adjuvants. Understanding these differences could be useful in several ways. First, it might help identify people whose disease is likely to respond to the study vaccine with the study adjuvants. Second, the information might be useful in developing other treatments for people whose disease does not respond to the study vaccine with the adjuvants.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV-1 gag DNA (formulated with bupivacaine) | Biological | |||
| IL-15 DNA (formulated with bupivacaine) | Biological | |||
| IL-12 DNA (formulated with bupivacaine) | Biological | |||
| Sodium chloride injection USP (0.9%) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of intramuscular administration of HIV-1 gag DNA vaccine (total of three doses) in individuals on stable HAART | ||
| intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-12 DNA following each vaccine dose (total of three doses) in individuals on stable HAART | ||
| intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-15 DNA following each vaccine dose (total of three doses) in individuals on stable HAART |
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Inclusion Criteria:
Other Inclusions Apply
Exclusion Criteria:
Other Exclusions Apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Germany, MedinfoDEU@wyeth.com | Principal Investigator |
| Trial Manager | For Sweden, MedInfoNord@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
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| Denver |
| Colorado |
| 80262 |
| United States |
| Orlando | Florida | 32803 | United States |
| Boston | Massachusetts | 02215 | United States |
| Austin | Texas | 78705 | United States |
| Dallas | Texas | 75246 | United States |
| Berlin | 12157 | Germany |
| Cologne | 50937 | Germany |
| Frankfurt | 60590 | Germany |
| Hamburg | 20246 | Germany |
| Hanover | 30625 | Germany |
| München | 80336 | Germany |
| Stockholm | 118 23 | Sweden |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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