HIV InfectionsNCT00000997
A Study of Dideoxycytidine in HIV-Infected Patients
A study testing Zalcitabine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
To determine how much of a dose is absorbed by the body when zalcitabine ( dideoxycytidine; ddC ) is given orally and how long the drug stays in the body after absorption or intravenous (IV) administration. Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes. 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?
- Zalcitabine
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 1988
- 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
- Prior Medication:
- Allowed:
- Oral nonabsorbable antifungal agents.
Who cannot join
- Active drug or alcohol abuse.
- Co-existing Condition:
- Patients with fever > 102 degrees F at study entry will be excluded.
- Patients with fever > 102 degrees F at study entry will be excluded.
- Prior Medication: Excluded:
- Chronic systemic medications.
Show all 16Show fewer
- Any other experimental drug within 2 weeks of study entry.
- Drugs with known nephrotoxic or hepatotoxic effects within 2 weeks of study entry.
- Drugs known to cause neutropenia within 2 weeks of study entry.
- Rifampin or rifampin derivatives, phenytoin, or barbiturates within 2 weeks of study entry.
- Any other medication except oral nonabsorbable antifungal agents within 72 hours of study entry.
- All medications, including aspirin, must be approved by investigator. All medications, including aspirin, must be approved by investigator.
- Patients must demonstrate the following clinical and laboratory findings:
- AIDS, AIDS related complex (ARC), or persistent generalized lymphadenopathy as defined by the CDC classification.
- No ascites.
- Off all medications except oral antifungal, nonabsorbable agents for 72 hours prior to study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Bioavailability of Dideoxycytidine in Patients With Human Immunodeficiency Virus Infection
To determine how much of a dose is absorbed by the body when zalcitabine ( dideoxycytidine; ddC ) is given orally and how long the drug stays in the body after absorption or intravenous (IV) administration.
Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes. The study will reveal the pharmacokinetic (blood levels) properties of this new drug and how long the drug remains in the body at each of six doses. This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation, such as a tablet or capsule, since dose-related problems will already be known.
Read the detailed description
Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes. The study will reveal the pharmacokinetic (blood levels) properties of this new drug and how long the drug remains in the body at each of six doses. This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation, such as a tablet or capsule, since dose-related problems will already be known.
Patients are hospitalized and receive ddC twice, once by mouth and once by IV injection. Each patient receives the drug at one of six increasing doses, and no patient is studied at more than one dose level. Following each dose, toxicity is measured before the next higher dose is given. Several blood samples and urine specimens are taken to permit measurement of the amount of drug in the bloodstream and of the speed with which it is eliminated from the body.
- Conditions
- HIV Infections
- Being tested
- Zalcitabine
- Keywords
- Zalcitabine, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Biological Availability
- 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.
ZalcitabineDrug
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)
- Study completionDec 1988
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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)
- Enrolment
- 12 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lietman P, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000997
- Sponsor's protocol ID
- ACTG 011
- Other IDs
- 10987
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Gustavson LE, Fukuda EK, Rubio FA, Dunton AW. A pilot study of the bioavailability and pharmacokinetics of 2',3'-dideoxycytidine in patients with AIDS or AIDS-related complex. J Acquir Immune Defic Syndr (1988). 1990;3(1):28-31.
PubMed 2152803
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Bioavailability of Dideoxycytidine in Patients With Human Immunodeficiency Virus Infection
- ClinicalTrials.gov ID
- NCT00000997
- Acronym / sponsor ID
- ACTG 011
- Conditions
- HIV Infections
- Keywords
- Zalcitabine, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Biological Availability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Dec 1988 (actual)
- 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 determine how much of a dose is absorbed by the body when zalcitabine ( dideoxycytidine; ddC ) is given orally and how long the drug stays in the body after absorption or intravenous (IV) administration.
Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes. The study will reveal the pharmacokinetic (blood levels) properties of this new drug and how long the drug remains in the body at each of six doses. This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation, such as a tablet or capsule, since dose-related problems will already be known.
Detailed description
Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes. The study will reveal the pharmacokinetic (blood levels) properties of this new drug and how long the drug remains in the body at each of six doses. This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation, such as a tablet or capsule, since dose-related problems will already be known.
Patients are hospitalized and receive ddC twice, once by mouth and once by IV injection. Each patient receives the drug at one of six increasing doses, and no patient is studied at more than one dose level. Following each dose, toxicity is measured before the next higher dose is given. Several blood samples and urine specimens are taken to permit measurement of the amount of drug in the bloodstream and of the speed with which it is eliminated from the body.
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 (3 listed)
- Oral nonabsorbable antifungal agents.
Key exclusion criteria (16 listed)
- Active drug or alcohol abuse.
- Patients with fever > 102 degrees F at study entry will be excluded.
- Patients with fever > 102 degrees F at study entry will be excluded.
- Chronic systemic medications.
- Any other experimental drug within 2 weeks of 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 |
|---|---|---|
| Zalcitabine | 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 4 Nov 2021.
- Background: PubMed 2152803Gustavson LE, Fukuda EK, Rubio FA, Dunton AW. A pilot study of the bioavailability and pharmacokinetics of 2',3'-dideoxycytidine in patients with AIDS or AIDS-related complex. J Acquir Immune Defic Syndr (1988). 1990;3(1):28-31.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Lietman P study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zalcitabine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 3 inclusion and 16 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 4 Nov 2021. 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?
On the ClinicalTrials.gov record for NCT00000997, 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 4 Nov 2021.