HIV InfectionsPhase 1NCT00002141
A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
A Phase 1 study testing Abacavir sulfate in people with HIV Infections, run by Burroughs Wellcome at 2 sites in United States.
Trial summary
To assess the safety of single oral doses of 1592U89 (abacavir succinate, ABC) administered to HIV-positive individuals. To determine the pharmacokinetics of 1592U89 after single oral doses. To determine the effects of food on the bioavailability of 1592U89. Read more about this study
- Who is it for?
- Ages 13 to 55 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Abacavir sulfate
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 1994to 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 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must have:
- HIV infection, as documented by ELISA/Western blot detection of HIV antibody, positive p24 antigen assay, positive viral culture, or other accepted technique.
- Written informed consent of parent or legal guardian if under age 18.
Who cannot join
- Co-existing Condition:
- Excluded:
- Debilitating disease, as a result of HIV or associated therapies, that, in the opinion of the investigator, might prevent the patient from completing 6-week dosing period.
- Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption.
- Concurrent Medication:
- Excluded:
Show all 16Show fewer
- Prescription or over-the-counter medication that cannot be withheld for 48 hours prior to dosing and during the 6 dosing periods. (Note:
- Antiretrovirals must be withheld for 24 hours prior to dosing and during the day of dosing.)
- Other investigational treatments (treatments available through a Treatment IND or other expanded access mechanism is evaluated individually in consultation with the sponsor).
- Alcoholic beverages within 48 hours before dosing and during the day of dosing.
- Coffee, tea, and other xanthine-containing beverages and foods on the day of dosing.
- Patients with the following symptoms or conditions are excluded:
- History of hepatitis, pancreatitis, or cardiomyopathy within the last 5 years.
- Risk Behavior:
- Excluded:
- Current alcohol or illicit drug use that might interfere with the patient's ability to comply with the dosing schedule and protocol evaluations, as determined by the investigator.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Ctr for Phase I Research
Wichita, Kansas, 67214
About this study
To assess the safety of single oral doses of 1592U89 (abacavir succinate, ABC) administered to HIV-positive individuals. To determine the pharmacokinetics of 1592U89 after single oral doses. To determine the effects of food on the bioavailability of 1592U89.
Read the detailed description
Patients are randomized in a double-blinded manner, with 12 patients entering the treatment arm and 6 patients entering the control arm. Patients in the treatment arm receive 6 single escalating doses of 1592U89 separated by at least a 6-day washout period. Patients in the control arm receive 6 single oral doses of placebo at least 6 days apart. The second and third doses of 1592U89 are equivalent. During these doses, investigators study the effects of food on the pharmacokinetics of 1592U89 by giving half of the patients the second dose with a standardized, high-fat breakfast and giving the other half the dose in a fasted state. During the third dose, patients are crossed over so that patients who received the second dose with a meal now receive it in a fasted state, and vice versa. Following the sixth dose, investigators break the blind. Patients who received 1592U89 take a seventh dose in solution form and return for follow-up at least 7 days later; patients who received placebo receive no further treatment or follow-up. Serial blood and urine samples are collected before and after each administration of 1592U89 (or placebo) for determination of plasma and urine concentrations of 1592U89, and investigators monitor patients closely for adverse events or abnormal laboratory test findings.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate
- Keywords
- Biological Availability, Reverse Transcriptase Inhibitors, Food-Drug Interactions, abacavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abacavir sulfateDrug
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 startJul 1994
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 1
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Burroughs Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002141
- Sponsor's protocol ID
- 238A
- Other IDs
- 001
- Status last verified
- Oct 1994
- 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
- A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
- ClinicalTrials.gov ID
- NCT00002141
- Acronym / sponsor ID
- 238A
- Conditions
- HIV Infections
- Keywords
- Biological Availability, Reverse Transcriptase Inhibitors, Food-Drug Interactions, abacavir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- Burroughs WellcomeIndustry (pharma, biotech, devices)
- Study start
- Jul 1994
- 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 of single oral doses of 1592U89 (abacavir succinate, ABC) administered to HIV-positive individuals. To determine the pharmacokinetics of 1592U89 after single oral doses. To determine the effects of food on the bioavailability of 1592U89.
Detailed description
Patients are randomized in a double-blinded manner, with 12 patients entering the treatment arm and 6 patients entering the control arm. Patients in the treatment arm receive 6 single escalating doses of 1592U89 separated by at least a 6-day washout period. Patients in the control arm receive 6 single oral doses of placebo at least 6 days apart. The second and third doses of 1592U89 are equivalent. During these doses, investigators study the effects of food on the pharmacokinetics of 1592U89 by giving half of the patients the second dose with a standardized, high-fat breakfast and giving the other half the dose in a fasted state. During the third dose, patients are crossed over so that patients who received the second dose with a meal now receive it in a fasted state, and vice versa. Following the sixth dose, investigators break the blind. Patients who received 1592U89 take a seventh dose in solution form and return for follow-up at least 7 days later; patients who received placebo receive no further treatment or follow-up. Serial blood and urine samples are collected before and after each administration of 1592U89 (or placebo) for determination of plasma and urine concentrations of 1592U89, and investigators monitor patients closely for adverse events or abnormal laboratory test findings.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- HIV infection, as documented by ELISA/Western blot detection of HIV antibody, positive p24 antigen assay, positive viral culture, or other accepted technique.
- Written informed consent of parent or legal guardian if under age 18.
Key exclusion criteria (16 listed)
- Debilitating disease, as a result of HIV or associated therapies, that, in the opinion of the investigator, might prevent the patient from completing 6-week dosing period.
- Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption.
- Prescription or over-the-counter medication that cannot be withheld for 48 hours prior to dosing and during the 6 dosing periods. (Note:
- Antiretrovirals must be withheld for 24 hours prior to dosing and during the day of dosing.)
- Other investigational treatments (treatments available through a Treatment IND or other expanded access mechanism is evaluated individually in consultation with the sponsor).
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 |
|---|---|---|
| Abacavir sulfate | 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Abacavir sulfate in people with HIV Infections, run by Burroughs Wellcome at 2 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 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 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 2 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?
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.