NCT00000988

Brief Summary

To evaluate the safety, minimum effective dose (MED), pharmacokinetics and efficacy of orally administered 2',3'-dideoxy-2',3'-didehydrothymidine (d4T) in patients with AIDS or AIDS related complex (ARC). To establish an appropriate dosage regimen of d4T to be employed in Phase II and III trials. To evaluate the effects of de-escalating doses of d4T on markers associated with HIV infection. Currently, the only FDA-approved therapy for patients with AIDS or ARC is zidovudine (AZT), a drug with significant value but limited use because of toxic effects on the bone marrow. d4T has not been tested in humans, but it has inhibited the reproduction of HIV (the virus that causes AIDS) in laboratory experiments. In some studies with laboratory animals, d4T was less toxic against blood cells than AZT.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

2 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

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

August 26, 2008

Status Verified

December 1, 1994

First QC Date

November 2, 1999

Last Update Submit

August 25, 2008

Conditions

HIV Infections

Keywords

Injections, IntravenousDrug EvaluationAdministration, OralAcquired Immunodeficiency SyndromeAIDS-Related ComplexAntiviral Agents

Interventions

StavudineDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis.
  • TMP/SMX as an alternative prophylactic agent, 1 DS tablet orally per day.
  • Acute therapy with oral acyclovir for herpes simplex infections for no more than 7 days, providing d4t is suspended Symptomatic therapy such as analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy may be administered for toxicities as deemed necessary by the principal investigator. For therapy of fever, aspirin rather than acetaminophen should be used.
  • Concurrent Treatment:
  • Allowed:
  • Transfusion of up to 2 units of packed red blood cells every 3 weeks for grade 3 or grade 4 anemia (see Recommendations for Grading of Acute and Subacute Toxic Effects (Adults)) until patient returns to baseline from grade 3 or to baseline or grade 1 from grade 4.
  • Patient must have:
  • AIDS or AIDS related complex (CDC Group IVA or CDC Group IVC-2 with thrush or oral leukoplakia).
  • Ability to provide informed consent.
  • Availability to follow-up for at least 6 months.
  • Absence of active, AIDS-defining opportunistic infection on study entry.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Active, AIDS-defining opportunistic infection.
  • Intractable diarrhea.
  • History or propensity for seizure disorders requiring anticonvulsants for control.
  • Any other clinical condition which in the opinion of the investigator would make the patient unsuitable or unable to comply with the dosing requirements.
  • Concurrent Medication:
  • Excluded:
  • Systemic therapy with this or any other antiretroviral drug (including AL-721, ddI, ddC, interferon, immunomodulating drugs) or investigational drug.
  • Ribavirin.
  • Cytotoxic anticancer therapy.
  • Therapy with any agent known as a potent inducer or inhibitor of drug-metabolizing enzymes, such as rifampin or barbiturates.
  • Systemic maintenance or chemoprophylaxis for opportunistic infections.
  • Trimethoprim / sulfamethoxazole for Pneumocystis carinii infections.
  • Acute therapy with ketoconazole for thrush.
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cornell Univ Med Ctr

New York, New York, 10021, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Related Publications (1)

  • Murray HW, Squires KE, Weiss W, Sledz S, Sacks HS, Hassett J, Cross A, Anderson RE, Dunkle LM. Stavudine in patients with AIDS and AIDS-related complex: AIDS clinical trials group 089. J Infect Dis. 1995 Mar;171 Suppl 2:S123-30. doi: 10.1093/infdis/171.supplement_2.s123.

    PMID: 7861017BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Stavudine

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)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • HS Sacks

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

August 26, 2008

Record last verified: 1994-12

Locations

US(2)