A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3.
SECONDARY: To determine whether significant advantages to any one vaccine exist.
Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: Aluminum hydroxide Biological: MF59 Biological: rgp120/HIV-1IIIB Biological: rgp120/HIV-1MN Biological: rgp120/HIV-1 SF-2 Biological: Env 2-3 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Primary Purpose: Prevention |
| Official Title: | A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3 |
| Estimated Enrollment: | 130 |
| Study Completion Date: | September 1996 |
Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.
Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Short-term nonsteroidal anti-inflammatory therapy.
Patients must have:
- HIV seropositivity.
- CD4 count >= 500 cells/mm3.
- Successful establishment of EBV-transformed B-cell lines at study entry.
- Consent of parent or guardian if < 18 years of age.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Suspected or known allergies to any vaccine components.
- Medical contraindication.
- Problem with compliance.
Concurrent Medication:
Excluded:
- Antiretroviral therapy (e.g., AZT, ddI, or ddC).
- Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin).
- Parenteral therapies (including SC allergy sensitization).
- Other investigational HIV drugs or therapies.
Prior Medication:
Excluded:
- Any prior vaccinations against HIV.
- Antiretroviral therapy (e.g., AZT, ddI, or ddC) within the past 6 months.
- Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin) within the past 3 months.
- Parenteral therapies (including SC allergy sensitization) within the past 3 months.
- Other investigational HIV drugs or therapies within the past 3 months.
Contacts and Locations| United States, California | |
| UCLA CARE Center CRS | |
| Los Angeles, California, United States | |
| Stanford CRS | |
| Palo Alto, California, United States, 94115 | |
| Santa Clara Valley Med. Ctr. | |
| San Jose, California, United States, 951282699 | |
| San Mateo County AIDS Program | |
| San Mateo, California, United States, 943055107 | |
| United States, Colorado | |
| University of Colorado Hospital CRS | |
| Aurora, Colorado, United States, 80262 | |
| United States, Massachusetts | |
| Massachusetts General Hospital ACTG CRS | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | |
| Boston, Massachusetts, United States, 02215 | |
| Bmc Actg Crs | |
| Boston, Massachusetts, United States, 02118 | |
| United States, New York | |
| NY Univ. HIV/AIDS CRS | |
| New York, New York, United States, 10016 | |
| United States, Washington | |
| University of Washington AIDS CRS | |
| Seattle, Washington, United States, 981224304 | |
| Study Chair: | Schooley RT | |
| Study Chair: | Walker B |
More Information
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000779 History of Changes |
| Other Study ID Numbers: | ACTG 214, 11191 |
| Study First Received: | November 2, 1999 |
| Last Updated: | May 23, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Vaccines, Synthetic HIV-1 Adjuvants, Immunologic AIDS-Related Complex |
HIV Envelope Protein gp120 AIDS Vaccines HIV Therapeutic Vaccine |
Additional relevant MeSH terms:
|
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 Adjuvants, Immunologic Aluminum Hydroxide Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013