HIV InfectionsNCT00002260
An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
A study testing Alovudine in people with HIV Infections, run by Lederle Laboratories at 1 site in United States.
Trial summary
To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation) after single doses in both the fed and fasting states; to assess the effect of food on the oral bioavailability of FLT Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Alovudine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- Positive ELISA test confirmed by Western blot analysis.
- Asymptomatic.
- Willing to sign an informed consent.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
- Oral hairy leukoplakia at any time prior to entry.
- Temperature > 37.8 C.
- Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
Show all 21Show fewer
- Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
- Unwilling to sign an informed consent.
- Zidovudine induced hematological toxicity.
- Prior Medication:
- Excluded:
- Therapy with antiretroviral drugs or immunomodulators within seven days before entry.
- Therapy with any investigational drug during the preceding 30 days.
- Patients may not have:
- Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
- Oral hairy leukoplakia at any time prior to entry.
- Temperature > 37.8 C.
- Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
- Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
- Unwilling to sign an informed consent.
- Zidovudine induced hematological toxicity.
Trial locations and contacts
1 site in 1 country.
About this study
To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation) after single doses in both the fed and fasting states; to assess the effect of food on the oral bioavailability of FLT
- Conditions
- HIV Infections
- Being tested
- Alovudine
- Keywords
- Biological Availability, alovudine, Food
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Lederle Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002260
- Sponsor's protocol ID
- 054C
- Other IDs
- 81-3
- Status last verified
- Mar 1992
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
- ClinicalTrials.gov ID
- NCT00002260
- Acronym / sponsor ID
- 054C
- Conditions
- HIV Infections
- Keywords
- Biological Availability, alovudine, Food
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Lederle LaboratoriesIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation) after single doses in both the fed and fasting states; to assess the effect of food on the oral bioavailability of FLT
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Positive ELISA test confirmed by Western blot analysis.
- Asymptomatic.
- Willing to sign an informed consent.
Key exclusion criteria (21 listed)
- Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
- Oral hairy leukoplakia at any time prior to entry.
- Temperature > 37.8 C.
- Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
- Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alovudine in people with HIV Infections, run by Lederle Laboratories at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.