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| Sponsor: | Pharmacia |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002435 |
Purpose
To investigate the safety of thymic humoral factor (THF gamma 2), its effect on HIV load based on at least a 75 percent decrease in HIV quantitative PCR RNA copies/ml, and its persistence when administered in combination with an antiretroviral nucleoside derivative (zidovudine; AZT). To assess the effects of THF gamma 2 on T-cells, quality of life, and progression of disease.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Thymic Humoral Factor Drug: Zidovudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | Study of the Activity of Thymic Humoral Factor (THF Gamma 2) on HIV Load in HIV-Positive Individuals With CD4+ Cell Counts in the Range of 200-500 Cells/mm3 |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Myositis within the past 6 months.
Prior Medication:
Excluded:
Prior Treatment:
Excluded within 6 weeks prior to study entry:
Contacts and Locations| United States, California | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| Gottlieb Med Group | |
| Sherman Oaks, California, United States, 91403 | |
| Southwest Community Based AIDS Treatment Group - COMBAT | |
| Los Angeles, California, United States, 90028 | |
| UCI | |
| Irvine, California, United States, 92717 | |
| United States, Florida | |
| Mem Hosp Hollywood | |
| Hollywood, Florida, United States, 33021 | |
| Goodgame Med Group | |
| Maitland, Florida, United States, 32751 | |
| United States, New York | |
| Chelsea Village Med Ctr | |
| New York, New York, United States, 10014 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 97210 | |
| United States, South Carolina | |
| Dr Alfred F Burnside Jr | |
| Columbia, South Carolina, United States, 29204 | |
| United States, Virginia | |
| Infectious Disease Physicians Inc | |
| Annandale, Virginia, United States, 22203 | |
More Information
| Study ID Numbers: | 136A, CS 112010-999 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002435 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Antiviral Agents Zidovudine thymic humoral factor gamma 2 |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Adjuvants, Immunologic Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Thymic humoral factor gamma 2 |