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A Multi-Center, Open-Label, Ascending, Multiple Oral Dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alovudine
Sponsored by
Lederle Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. Up to 14 days of systemic therapy for minor opportunistic infections such as candidiasis, mucocutaneous Herpes simplex or cutaneous Herpes zoster infections. Patients must have the following: AIDS or AIDS related complex (ARC) as defined by the CDC. Positive antibody to HIV as determined by a commercially licensed ELISA test kit, confirmed by Western blot analysis. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Symptomatic visceral Kaposi's sarcoma or progression of Kaposi's sarcoma within the month prior to study entry (progression is defined as more than a 25 percent increase in the product of bidirectional measurement of indicator lesions and/or more than a 25 percent increase in the number of new lesions). Concurrent neoplasms other than Kaposi's sarcoma or basal cell carcinoma of the skin. Patients who have had a malignancy in the past that has been in complete remission for 1 year without therapy may be enrolled. Signs or symptoms of neuropathy and a Vibratron 2 score = or > 4 for either great toe. Concurrent Medication: Excluded: Acute therapy for AIDS-related infection. Systemic maintenance therapy for AIDS-defining opportunistic infection. Recombinant erythropoietin. Long term therapy with either aspirin or probenecid. Concurrent Treatment: Excluded: Blood transfusion more than once per month. Patients with the following are excluded: Symptomatic visceral Kaposi's sarcoma or progression of Kaposi's sarcoma within the month prior to study entry. Unwilling to sign an informed consent or patients unwilling to be followed at the medical center where they were enrolled for the duration of the study and follow-up as required. History of intolerance to zidovudine (AZT) at any dose as demonstrated by an AZT related decrease in hemoglobin levels of at least 2 g/dl or AZT related depression of neutrophils of at least 200 cells/mm3 to < 750 cells/mm3 which required discontinuation of AZT therapy. Diseases or conditions listed in Exclusion Co-Existing Conditions. Prior Medication: Excluded: Antiretroviral agents within 14 days of study entry. Immunomodulating agents or corticosteroids within 30 days prior to study entry. Treatment for acute Pneumocystis carinii pneumonia within 2 weeks prior to study entry. Prior Treatment: Excluded: Blood transfusions within 7 days prior to study entry. Radiation therapy for Kaposi's sarcoma within 30 days prior to study entry. Active substance abuse.

Sites / Locations

  • Johns Hopkins Hosp
  • Mem Sloan - Kettering Cancer Ctr
  • Univ of North Carolina School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Lederle Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00002254
Brief Title
A Multi-Center, Open-Label, Ascending, Multiple Oral Dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)
Official Title
A Multi-Center, Open-Label, Ascending, Multiple Oral Dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)
Study Type
Interventional

2. Study Status

Record Verification Date
May 1991
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Lederle Laboratories

4. Oversight

5. Study Description

Brief Summary
To assess the tolerance and toxicity profile of deoxy-3'-fluorothymidine (FLT) after multiple oral dosing for 16 weeks. To characterize the steady-state pharmacokinetics of FLT after multiple oral doses. To assess the effect of FLT on immunologic and virologic markers of HIV infection (CD4+ lymphocyte count, p24 antigen, viremia) in patients with AIDS or AIDS related complex (ARC) after multiple oral dosing for 16 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. Up to 14 days of systemic therapy for minor opportunistic infections such as candidiasis, mucocutaneous Herpes simplex or cutaneous Herpes zoster infections. Patients must have the following: AIDS or AIDS related complex (ARC) as defined by the CDC. Positive antibody to HIV as determined by a commercially licensed ELISA test kit, confirmed by Western blot analysis. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Symptomatic visceral Kaposi's sarcoma or progression of Kaposi's sarcoma within the month prior to study entry (progression is defined as more than a 25 percent increase in the product of bidirectional measurement of indicator lesions and/or more than a 25 percent increase in the number of new lesions). Concurrent neoplasms other than Kaposi's sarcoma or basal cell carcinoma of the skin. Patients who have had a malignancy in the past that has been in complete remission for 1 year without therapy may be enrolled. Signs or symptoms of neuropathy and a Vibratron 2 score = or > 4 for either great toe. Concurrent Medication: Excluded: Acute therapy for AIDS-related infection. Systemic maintenance therapy for AIDS-defining opportunistic infection. Recombinant erythropoietin. Long term therapy with either aspirin or probenecid. Concurrent Treatment: Excluded: Blood transfusion more than once per month. Patients with the following are excluded: Symptomatic visceral Kaposi's sarcoma or progression of Kaposi's sarcoma within the month prior to study entry. Unwilling to sign an informed consent or patients unwilling to be followed at the medical center where they were enrolled for the duration of the study and follow-up as required. History of intolerance to zidovudine (AZT) at any dose as demonstrated by an AZT related decrease in hemoglobin levels of at least 2 g/dl or AZT related depression of neutrophils of at least 200 cells/mm3 to < 750 cells/mm3 which required discontinuation of AZT therapy. Diseases or conditions listed in Exclusion Co-Existing Conditions. Prior Medication: Excluded: Antiretroviral agents within 14 days of study entry. Immunomodulating agents or corticosteroids within 30 days prior to study entry. Treatment for acute Pneumocystis carinii pneumonia within 2 weeks prior to study entry. Prior Treatment: Excluded: Blood transfusions within 7 days prior to study entry. Radiation therapy for Kaposi's sarcoma within 30 days prior to study entry. Active substance abuse.
Facility Information:
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Mem Sloan - Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Univ of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Barditch-Crovo PA, Kornhauser DM, Petty BG, Nerhood LJ, Lietman PS, Faulkner R, Ganes D, Kuye O, Flexner C. Phase I pharmacokinetic evaluation of 3'deoxy-3'-fluorothymidine (FLT), a new potent anti-HIV nucleoside. Int Conf AIDS. 1991 Jun 16-21;7(2):210 (abstract no WB2114)
Results Reference
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Learn more about this trial

A Multi-Center, Open-Label, Ascending, Multiple Oral Dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)

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