HIV InfectionsPhase 1NCT00002338
The Safety and Effectiveness of 935U83 in HIV-Infected Patients
A Phase 1 study testing Raluridine in people with HIV Infections, run by Glaxo Wellcome at 7 sites in United States.
Trial summary
To assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of 935U83 administered to patients with HIV infection. To obtain preliminary evidence of antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug resistance. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Raluridine
- How many people
- 40 participants
- Where
- 7 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Recommended:
- PCP prophylaxis for patients whose CD4 counts fall below 200 cells/mm3 or who develop PCP during study participation.
- Allowed:
- Acute treatment and secondary prophylaxis for tuberculosis, Mycobacterium avium intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection.
- Patients must have:
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- HIV infection.
- CD4 count 200 - 500 cells/mm3.
- No history of or current AIDS-defining indicator disease by CDC criteria.
- No antiretroviral therapy within the past 6 months.
- Consent of parent or guardian if less than 18 years of age.
Who cannot join
- Co-existing Condition:
- Patient with the following symptoms or conditions are excluded:
- Current evidence of chronic hepatitis of any etiology.
- Seropositivity for HBsAg or hepatitis C virus by second generation ELISA.
- Concurrent Medication:
- Excluded:
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- Cytotoxic chemotherapy.
- Other antiretroviral drugs.
- Immunomodulators.
- Foscarnet.
- GM-CSF or G-CSF.
- Erythropoietin.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following prior conditions are excluded:
- History of chemical, viral, or alcohol-induced clinical hepatitis within the past 3 years.
- Prior Medication:
- Excluded within the past 6 months:
- Any antiretroviral therapy.
- HIV immunotherapeutic vaccine.
- Excluded within the past 4 weeks:
- Cytotoxic chemotherapy.
- Immunomodulating agents such as systemic corticosteroids, IL-2, alpha interferon, beta interferon, or gamma interferon.
- Prior Treatment:
- Excluded within the past 4 weeks:
- Radiation therapy. Current alcohol or illicit drug use that may interfere with study compliance.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, 45267
Duke Univ Med Ctr
Durham, North Carolina, 27710
Indiana Univ Hosp
Indianapolis, Indiana, 46202
Goodgame Med Group
Maitland, Florida, 32751
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, 15261
ViRx Inc
San Francisco, California, 94103
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase I Trial to Evaluate the Safety, Tolerance, and Pharmacokinetics of 935U83 After Multiple Dosing in Patients With HIV Infection
To assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of 935U83 administered to patients with HIV infection. To obtain preliminary evidence of antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug resistance. To determine the effects of 935U83 dosing on CD4+ cell counts.
Read the detailed description
Patients (10 per dose level) are randomized to receive 1 of 4 doses of 935U83 every 8 hours for 12 weeks. Five patients at each dose level must complete 4 weeks of treatment without serious toxicity before subsequent patients are entered at the next higher dose. If lack of antiretroviral effect or unacceptable toxicity is demonstrated at a particular dose level, the dose regimens may be adjusted.
- Conditions
- HIV Infections
- Being tested
- Raluridine
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaluridineDrug
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002338
- Sponsor's protocol ID
- 237A
- Other IDs
- 02
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Riddler SA, McMahon DK, Bartlett JA, Savina PM, Wang LH, Dunn JA, Mellors JW. A phase I single-dose trial to evaluate the safety and pharmacokinetics (PK) of 5-chloro-2'3'-dideoxy- 3'fluorouridine (935U83). Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:160
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
- A Phase I Trial to Evaluate the Safety, Tolerance, and Pharmacokinetics of 935U83 After Multiple Dosing in Patients With HIV Infection
- ClinicalTrials.gov ID
- NCT00002338
- Acronym / sponsor ID
- 237A
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Glaxo WellcomeIndustry (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 assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of 935U83 administered to patients with HIV infection. To obtain preliminary evidence of antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug resistance. To determine the effects of 935U83 dosing on CD4+ cell counts.
Detailed description
Patients (10 per dose level) are randomized to receive 1 of 4 doses of 935U83 every 8 hours for 12 weeks. Five patients at each dose level must complete 4 weeks of treatment without serious toxicity before subsequent patients are entered at the next higher dose. If lack of antiretroviral effect or unacceptable toxicity is demonstrated at a particular dose level, the dose regimens may be adjusted.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- PCP prophylaxis for patients whose CD4 counts fall below 200 cells/mm3 or who develop PCP during study participation.
- Acute treatment and secondary prophylaxis for tuberculosis, Mycobacterium avium intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection.
- HIV infection.
- CD4 count 200 - 500 cells/mm3.
- No history of or current AIDS-defining indicator disease by CDC criteria.
Key exclusion criteria (27 listed)
- Current evidence of chronic hepatitis of any etiology.
- Seropositivity for HBsAg or hepatitis C virus by second generation ELISA.
- Cytotoxic chemotherapy.
- Other antiretroviral drugs.
- Immunomodulators.
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 |
|---|---|---|
| Raluridine | 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.
- BackgroundRiddler SA, McMahon DK, Bartlett JA, Savina PM, Wang LH, Dunn JA, Mellors JW. A phase I single-dose trial to evaluate the safety and pharmacokinetics (PK) of 5-chloro-2'3'-dideoxy- 3'fluorouridine (935U83). Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:160
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Raluridine in people with HIV Infections, run by Glaxo Wellcome at 7 sites 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 11 inclusion and 27 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 7 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
On the ClinicalTrials.gov record for NCT00002338, which also lists 1 linked publication.
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.