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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: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
| 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 | |
| UCI | |
| Irvine, California, United States, 92717 | |
| Southwest Community Based AIDS Treatment Group - COMBAT | |
| Los Angeles, California, United States, 90028 | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| Gottlieb Med Group | |
| Sherman Oaks, California, United States, 91403 | |
| 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
| ClinicalTrials.gov Identifier: | NCT00002435 History of Changes |
| Other Study ID Numbers: | 136A, CS 112010-999 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Antiviral Agents Zidovudine thymic humoral factor gamma 2 |
|
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 Zidovudine Thymic humoral factor gamma 2 Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |