HIV InfectionsNCT00002023
An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2
A study testing Zidovudine in people with HIV Infections, run by Glaxo Wellcome at 1 site in United States.
Trial summary
To establish the relationship between the oral dose of zidovudine (AZT) and its hematologic toxicity. AZT has preliminarily been shown to decrease significant events and death in a group of AIDS / Pneumocystis carinii pneumonia (PCP) and AIDS related complex (ARC) patients followed at this time for a limited period. 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?
- Zidovudine
- 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 HIV reactivity.
- Patients must belong to one of the following three groups according to the CDC classification:
- IIB - including only those patients with autoimmune thrombocytopenia (platelet count = or < 100000 platelets/mm3).
- OR Lymphopenia (lymphocyte count = or < 1000 cells/mm3).
- OR Helper cell lymphopenia (helper cells < the mean of normals).
- OR CDC classification III or IV-C2.
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- Patients with = or < involuntary 10 percent weight loss in the last 6 months.
- ECOG performance status 0 or 1.
- Weigh 70 kg + or - 15 kg in order to standardize the g/kg dosing.
- Positive antibody for HIV by an ELISA test kit. If the ELISA is negative, then eligibility will be confirmed by second confirmatory test, i.e., immunoblot.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- AIDS or the CDC classification stage IV except stage IV-C2.
- HIV antibody negative by immunoblot.
- Persistent fevers of > 38.5 degrees C.
- Persistent diarrhea undiagnosed > 1 month.
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- Involuntary weight loss of > 10 percent in the 6 months prior to study entry.
- ECOG performance status of 2, 3, or 4.
- Class IV-C2 with prior history of:
- Multidermal herpes zoster.
- Oral candidiasis on more than one occasion.
- Tuberculosis.
- Concurrent Medication:
- Excluded:
- Other antiretroviral agents.
- Active immunomodulating agents.
- Any other experimental therapy.
- Drugs which cause anemia or neutropenia.
- Drugs which are glucuronidated and may interfere with the metabolism of AZT, i.e., acetaminophen > 5 days.
- Acyclovir systemically administered > 5 days.
- Any other experimental agents.
- Patients with the following are excluded:
- AIDS or the CDC classification stage IV except stage IV-C2.
- HIV antibody negative by immunoblot.
- Persistent fevers of > 38.5 degrees C.
- Persistent diarrhea undiagnosed > 1 month.
- Involuntary weight loss of > 10 percent in the 6 months prior to study entry.
- ECOG performance status of 2, 3, or 4.
- Class IV-C2 with prior history of:
- Multidermal herpes zoster.
- Oral candidiasis on more than one occasion.
- Tuberculosis.
- Prior Medication:
- Excluded within 3 months of study entry:
- Other antiretroviral agents. Active immunomodulating agents.
- Excluded within 2 weeks of study entry:
- Drugs which cause anemia or neutropenia.
- Drugs which are glucuronidated and may interfere with the metabolism of zidovudine (AZT), i.e., acetaminophen > 5 days.
- Acyclovir systemically administered > 5 days.
- Any other experimental agents.
- Known active drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
About this study
To establish the relationship between the oral dose of zidovudine (AZT) and its hematologic toxicity. AZT has preliminarily been shown to decrease significant events and death in a group of AIDS / Pneumocystis carinii pneumonia (PCP) and AIDS related complex (ARC) patients followed at this time for a limited period. If these data withstand further follow-up, it appears that AZT is a potential antiretroviral agent that may have application in the use of all stages of HIV disease. At this time the optimal dose that will not cause significant toxicity is not known. If this drug has widespread application, it becomes imperative to further study both the dose and the toxicity. Patients with documented HIV viremia and who are well will be evaluated in a dose-escalating protocol for toxicity, persistent viremia, evidence of improvement of immune dysfunction, and the development of further manifestation of HIV disease. Drug levels will be monitored and correlated with the toxicity and viremia.
- Conditions
- HIV Infections
- Being tested
- Zidovudine
- Keywords
- Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- 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.
ZidovudineDrug
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
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002023
- Sponsor's protocol ID
- 014C
- Other IDs
- 013
- Status last verified
- Feb 1995
- 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 Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2
- ClinicalTrials.gov ID
- NCT00002023
- Acronym / sponsor ID
- 014C
- Conditions
- HIV Infections
- Keywords
- Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Study type
- Interventional
- Recruitment status
- Completed
- 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 establish the relationship between the oral dose of zidovudine (AZT) and its hematologic toxicity. AZT has preliminarily been shown to decrease significant events and death in a group of AIDS / Pneumocystis carinii pneumonia (PCP) and AIDS related complex (ARC) patients followed at this time for a limited period. If these data withstand further follow-up, it appears that AZT is a potential antiretroviral agent that may have application in the use of all stages of HIV disease. At this time the optimal dose that will not cause significant toxicity is not known. If this drug has widespread application, it becomes imperative to further study both the dose and the toxicity. Patients with documented HIV viremia and who are well will be evaluated in a dose-escalating protocol for toxicity, persistent viremia, evidence of improvement of immune dysfunction, and the development of further manifestation of HIV disease. Drug levels will be monitored and correlated with the toxicity and viremia.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have HIV reactivity.
- Patients must belong to one of the following three groups according to the CDC classification:
- IIB - including only those patients with autoimmune thrombocytopenia (platelet count = or < 100000 platelets/mm3).
- OR Lymphopenia (lymphocyte count = or < 1000 cells/mm3).
- OR Helper cell lymphopenia (helper cells < the mean of normals).
Key exclusion criteria (41 listed)
- AIDS or the CDC classification stage IV except stage IV-C2.
- HIV antibody negative by immunoblot.
- Persistent fevers of > 38.5 degrees C.
- Persistent diarrhea undiagnosed > 1 month.
- Involuntary weight loss of > 10 percent in the 6 months prior to study entry.
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 |
|---|---|---|
| Zidovudine | 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 Zidovudine in people with HIV Infections, run by Glaxo Wellcome 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 10 inclusion and 41 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.