NCT00001015

Brief Summary

To determine the maximum long-term dosage of ribavirin (RBV) that is safe and free of serious side effects in patients with AIDS or AIDS related illnesses. Also, to determine what effect different dosage levels have on biologic markers of efficacy, such as the amount of the AIDS virus (HIV) or number of T cells in the patient's blood. RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

June 1, 1990

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

RibavirinT-LymphocytesAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

RibavirinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Short-course therapy (7 days) with oral acyclovir.
  • Short-course therapy (7 days) with ketoconazole.
  • Topical medications.
  • Aerosolized pentamidine for prophylactic purposes.
  • Concurrent Treatment:
  • Allowed:
  • Blood transfusions for hemoglobin toxicity.
  • Patients must have two positive HIV p24 antigen tests with titers = or \> 70 picograms at least 72 hours apart and within 1 month prior to entry, the last of which must be within 2 weeks of starting therapy.
  • Prior Medication:
  • Allowed:
  • Zidovudine (AZT), without cessation of therapy required due to intolerance.
  • AZT therapy must be discontinued at least 30 days prior to study entry.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or \> 3 liquid stools per day within the past week.
  • Concurrent Medication:
  • Excluded:
  • Ongoing systemic therapy and/or prophylaxis for an AIDS-defining opportunistic infection.
  • Antineoplastic therapy.
  • Other experimental medications.
  • Systemic chemoprophylaxis for Pneumocystis carinii pneumonia.
  • Chronic (\> 7 days) oral acyclovir therapy.
  • Concurrent Treatment:
  • Excluded:
  • Blood transfusions unless they are for = or \> grade 3 hemoglobin toxicity.
  • Patients with the following are excluded:
  • Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or \> 3 liquid stools per day within the past week.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Univ of California / San Diego Treatment Ctr

San Diego, California, 921036325, United States

Location

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, 02114, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Univ of North Carolina

Chapel Hill, North Carolina, 275997215, United States

Location

Related Publications (2)

  • Crumpacker C, Pearlstein G, van der Horst C, Valentine F, Spector S, Mills J. A phase one increasing dose trial of oral ribavirin (RBV) in patients with AIDS and ARC. Int Conf AIDS. 1990 Jun 20-23;6(3):203 (abstract no SB468)

    BACKGROUND

  • Crumpacker C, Cotton D, Pearlstein G, Valentine F, Mills J, Spector S. Ribavirin dose escalating phase 1 trial in patients with AIDS and ARC. Int Conf AIDS. 1989 Jun 4-9;5:336 (abstract no TBP296)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Crumpacker C

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

June 1, 1990

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(5)