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| Sponsor: | ICN Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002298 |
Purpose
The objective of this clinical trial is to determine whether long-term oral dosage of ribavirin delays development of symptomatic HIV disease in HIV antibody positive subjects who are completely asymptomatic (CDC classification group II), who have only the lymphadenopathy syndrome (CDC classification group III), or who have clinical symptoms but not severe HIV disease as defined by CDC classification, and whether the dosage regimen is safe and tolerable in these subjects.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Ribavirin |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Long-Term Efficacy and Tolerance of Oral Ribavirin Compared to Placebo as a Preventative in Early Stages of Human Immunodeficiency Virus Infection - United States |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Positive plasma p24 antigen.
Prior Medication:
Excluded within 4 weeks of start of screening tests:
HIV infection group II (CDC), asymptomatic HIV infection.
Contacts and Locations
More Information
| Study ID Numbers: | 013A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002298 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Ribavirin AIDS-Related Complex |
|
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Ribavirin Acquired Immunodeficiency Syndrome |
Infection Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |