Suspended

Long-Term Oral Ribavirin for Delaying Symptomatic HIV Disease in Asymptomatic HIV-Positive Individuals

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What is being tested

Ribavirin

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

From 18 to 60 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorICN Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This clinical trial aims to explore the benefits and safety of a long-term oral treatment with ribavirin for individuals in the early stages of Human Immunodeficiency Virus (HIV) infection. The study focuses on individuals who are HIV positive but do not show any symptoms (CDC classification group II), those who only have lymphadenopathy syndrome (CDC classification group III), and those who have clinical symptoms but not severe HIV disease as defined by the CDC. The goal is to understand if ribavirin can delay the progression of HIV disease in these individuals. Participants in this study will receive either ribavirin or a placebo (a pill with no active ingredients) orally. The study will monitor the participants' health over time to see if ribavirin is effective in delaying the onset of HIV symptoms. It will also assess the safety and tolerability of ribavirin in these individuals, checking for any potential side effects or complications.

NCT00002298
Principal SponsorICN Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAIDS-Related ComplexHIV Infections

Criteria

7 inclusion criteria required to participate
Ability to participate as outpatient: Ambulatory, competent to sign informed consent, and able to cooperate with the treatment plan and evaluation schedule
Allowed concurrent medication: Acyclovir
Conclusion of screening tests within 42 days of starting them. Patients must be entered into the study within 14 days of screening completion
HIV antibody positive by Western blot with antibodies to p24 band and GP160 band and/or GP41. Two positive tests during screening will be required. CDC HIV infection group II, asymptomatic HIV infection, as defined in Appendix A, or CDC HIV infection group III, persistent generalized lymphadenopathy (PGL, formerly LAS)
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11 exclusion criteria prevent from participating
CDC classification group IV A (ARC)
CDC classification group IV C-1 (AIDS) and IV C-2 (including Thrush or Herpes zoster during the past 2 years). Positive plasma p24 antigen
Failure to give informed consent
Splenectomy
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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