NCT00002014

Brief Summary

To determine the safety and tolerance of various combinations of zidovudine (AZT) and didanosine (ddI) administered concurrently. To determine the pharmacokinetics of concurrent AZT and ddI administered orally. To evaluate the antiviral, immunologic and virologic effects of AZT and ddI administered concurrently.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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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

June 24, 2005

Status Verified

August 1, 1991

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

DidanosineDrug EvaluationZidovudine

Interventions

ZidovudineDRUG
DidanosineDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Acyclovir not to exceed two 14-day courses of therapy during trial. Discontinue ddI while receiving acyclovir.
  • Patients must have the following:
  • Positive HIV antibody using federally licensed ELISA test kit.
  • CD4 counts \< 400 on two consecutive visits within one month prior to entry.
  • Prior Medication:
  • Allowed:
  • Zidovudine (AZT) if treated for less than 120 days.
  • Pharmacologic doses of steroids if given for management of Pneumocystis carinii pneumonia (PCP) (not to exceed 21 days).

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • \- Visceral or progressive Kaposi's sarcoma (KS) (defined by \> 10 new lesions in the thirty days prior to entry) or patients who require chemotherapy or radiation therapy for Kaposi's sarcoma. Other concurrent neoplasms other than basal cell carcinoma of skin or in situ carcinoma of the cervix. Malabsorption as defined by persistent diarrhea ( \> 4 stools/day for four weeks) which is unresponsive to antidiarrheal agents. Opportunistic infection requiring maintenance therapy. History of Central Nervous System opportunistic infections (e.g., toxoplasmosis, cryptococcosis). History of seizure disorders. Prior history of pancreatitis. History of peripheral neuropathy or any significant signs or symptoms of neurological disease. Examinations for peripheral neuropathy should assess changes in extremities. Clinically significant hyperuricemia (tophaceous gout, urate nephropathy). History of cardiomyopathy.
  • Concurrent Medication:
  • Excluded:
  • Intravenous pentamidine.
  • Intravenous trimethoprim / sulfamethoxazole.
  • Alcohol.
  • Allopurinol.
  • Probenecid.
  • Isoniazid (INH).
  • Dipyridamole.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy for Kaposi's sarcoma.
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

New England Med Ctr

Boston, Massachusetts, 02111, United States

Location

Univ of Washington

Seattle, Washington, 981224304, United States

Location

Related Publications (1)

  • Lorenzen S, Quante M, Rauscher I, Slotta-Huspenina J, Weichert W, Feith M, Friess H, Combs SE, Weber WA, Haller B, Angele M, Albertsmeier M, Blankenstein C, Kasper S, Schmid RM, Bassermann F, Schwaiger M, Liffers ST, Siveke JT. PET-directed combined modality therapy for gastroesophageal junction cancer: Results of the multicentre prospective MEMORI trial of the German Cancer Consortium (DKTK). Eur J Cancer. 2022 Nov;175:99-106. doi: 10.1016/j.ejca.2022.07.027. Epub 2022 Sep 10.

    PMID: 36099671DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

ZidovudineDidanosine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesInosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingRibonucleosides

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1991-08

Locations

US(4)