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Sponsored by: |
Glaxo Wellcome |
---|---|
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002048 |
To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) in HIV-infected adult patients without clinical manifestations of disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.
Condition | Intervention |
---|---|
Lymphatic Disease HIV Infections |
Drug: Zidovudine |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III) |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Patients are excluded if they have a history of symptoms characteristic of CDC class I or IV including any of the following:
Prior Medication:
Excluded:
- Previous treatment for greater than 3 months duration with any antiretroviral compound such as zidovudine (AZT).
Excluded within 4 weeks of study entry:
- Treatment with any potentially myelosuppressive drug, nephrotoxic agent, or other experimental therapy.
Excluded within 3 months of study entry:
- Antiretroviral drugs or biologic response modifiers.
Excluded within 4 months of study entry:
- Systemic corticosteroids.
Patients must meet the following criteria:
Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Study ID Numbers: | 014J, 21 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002048 |
Health Authority: | United States: Food and Drug Administration |
Acquired Immunodeficiency Syndrome Zidovudine |
Virus Diseases Lymphatic Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |