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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002048 |
Purpose
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) |
Eligibility| 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.
Contacts and Locations
Show 22 Study Locations
More Information
| Study ID Numbers: | 014J, 21 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002048 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acquired Immunodeficiency Syndrome Zidovudine |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action 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 Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Lymphatic Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |