ClinicalTrials.gg
CompletedNCT00002254Updated Jun 24, 2005

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)

An interventional study of Alovudine in HIV Infections, sponsored by Lederle Laboratories. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Primary conditionAcquired Immunodeficiency SyndromeRegistry: HIV InfectionsReclassifiedWhy we changed it
Registry
HIV Infections — the first condition term the registry derived for this study.
ClinicalTrials.gg
Acquired Immunodeficiency Syndrome
Why
  1. The study's title name Acquired Immunodeficiency Syndrome, a narrower term within HIV Infections.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Lederle Laboratories · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States — 111 open to participants now, 153 under way, 9 of them phase 3. Acquired Immunodeficiency Syndrome · United States.

No phase
642 of 1,670
59 open now
Registered
3rd of 1,670
by date

Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, this one is one of 642 with no phase, and was the 3rd registered.

Acquired Immunodeficiency Syndrome

3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.

Browse Acquired Immunodeficiency Syndrome studies →

Open to participants now

111 of the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States are open now. Recruiting first, the newest first:

106 more — sign in →

All 111 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • HIV Infections

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Keywords

  • Acquired Immunodeficiency Syndrome
04

In context

Acquired Immunodeficiency Syndrome Reclassified

3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Lederle Laboratories is the lead sponsor of 6 studies on the registry; none are open to participants now.

Compared within Acquired Immunodeficiency Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is HIV Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 as determined by a commercially licensed ELISA test kit, confirmed by Western blot analysis.

Exclusion criteria

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 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 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 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 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.

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

06

Study design

Phase
Not applicable
Primary purpose
Treatment

Interventions

07

Study locations

3 sites
  • Johns Hopkins Hosp
    Baltimore, Maryland 21287, United States
  • Mem Sloan - Kettering Cancer Ctr
    New York, New York 10021, United States
  • Univ of North Carolina School of Medicine
    Chapel Hill, North Carolina 275997215, United States
08

References and documents

Publications

  • 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)
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00002254
Lead sponsor
Lederle Laboratories
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 1991. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Alovudine

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