HIV InfectionsPhase 1NCT00000628
A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine
A Phase 1 study testing L-697,661 and Zidovudine in people with HIV Infections, run by Merck Sharp & Dohme LLC at 5 sites in United States.
Trial summary
Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661. 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?
- L-697,661 and Zidovudine
- How many people
- 27 participants
- Where
- 5 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- HIV infection.
- Prior Medication: Included:
- Patients in Part 1 must have received no previous zidovudine (AZT) or a stable dose of at least 500 mg/day without evidence of toxicity.
- Patients in Part 2 must have received no previous AZT or = or > 300 mg/day for < 6 consecutive weeks within 1 year prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Acute HIV-related opportunistic infection requiring ongoing treatment.
- Diarrhea defined as 3 or more liquid stools/day for one week.
- Wilson's or Gilbert's disease, porphyria, or other chronic or acute hepatic disease.
- Potentially life-threatening allergic reactions to any of the components of zidovudine.
Show all 24Show fewer
- Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study.
- Concurrent Medication:
- Excluded:
- Systemic bronchodilators, acetaminophen, aspirin.
- Prior Medication:
- Excluded:
- Didanosine (ddI) or dideoxycytidine (ddC) within 14 days prior to entry.
- Immune modulators or investigational drugs within 30 days prior to entry.
- Drugs known to induce hepatocellular enzymes, such as phenobarbital, phenytoin, warfarin, ketoconazole, and oral contraceptives, within 30 days prior to entry.
- Patients in Part 2 only:
- Excluded:
- Zidovudine within 4 weeks prior to receiving first dose of study drug.
- Risk Behavior:
- Excluded:
- Patients who the investigator feels would not comply with study requirements.
- Patients may not have the following prior conditions:
- Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study.
- Potentially life-threatening allergic reactions to any of the components of zidovudine.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern Univ Med School
Chicago, Illinois, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ of Colorado Health Ctr / Denver Gen Hosp
Denver, Colorado, 80262
San Francisco Gen Hosp
San Francisco, California, 941102859
Univ of Washington
Seattle, Washington, 981224304
About this study
Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661.
L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
Read the detailed description
L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
Part 1: Twelve patients are randomly assigned to one of two groups. Group 1 patients receive AZT for 7 days, followed by AZT plus L-697,661 with food for 56 days. Group 2 patients receive no drug for 7 days, followed by L-697,661 with food for 56 days. Antipyrine is administered 1 hour prior to study drug on days 8, 22, and 35.
Part 2: Fifteen patients receive L-697,661 with food, for 8 weeks. Therapy with L-697,661 may be extended beyond 8 weeks for up to 24 weeks.
- Conditions
- HIV Infections
- Being tested
- L-697,661, Zidovudine
- Keywords
- Drug Evaluation, Drugs, Investigational, Drug Therapy, Combination, 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.
L-697,661Drug
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.
- Publications (3)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 Merck Sharp & Dohme LLCThe 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 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 27 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- RT Schooley, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000628
- Sponsor's protocol ID
- ACTG 184
- Other IDs
- Merck Protocol 020-00
- Status last verified
- Oct 1994
- First submitted
- 2 Nov 1999
- Last updated
- 30 Jul 2008
- Results posted
- No
Publications
Kuritzkes DR, Curtis S, Rosandich M, Stein DS, Schooley RT. Delayed emergence of resistance to L-697,661 in patients receiving concomitant zidovudine. The ACTG 184 Study Team. Int Conf AIDS. 1993 Jun 6-11;9(1):467 (abstract no PO-B26-1994)
Schooley RT, Campbell TB, Kuritzkes DR, Blaschke T, Stein DS, Rosandich ME, Phair J, Pottage JC, Messari F, Collier A, Kahn J. Phase 1 study of combination therapy with L-697,661 and zidovudine. The ACTG 184 Protocol Team. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Aug 1;12(4):363-70. doi: 10.1097/00042560-199608010-00006.
PubMed 8673545Campbell TB, Routh JA, Bakhtiari M, Schooley RT, Kuritzkes DR. Detection of genotypic changes in reverse transcriptase during combination therapy with zidovudine and L-697,661. Detection of genotypic changes in reverse transcriptase during combination therapy with zidovudine and L-697,661. Int Conf AIDS. 1993 Jun 6-11;9(1):239 (abstract no PO-A26-0630)
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine
- ClinicalTrials.gov ID
- NCT00000628
- Acronym / sponsor ID
- ACTG 184
- Conditions
- HIV Infections
- Keywords
- Drug Evaluation, Drugs, Investigational, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- 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.
Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661.
L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
Detailed description
L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
Part 1: Twelve patients are randomly assigned to one of two groups. Group 1 patients receive AZT for 7 days, followed by AZT plus L-697,661 with food for 56 days. Group 2 patients receive no drug for 7 days, followed by L-697,661 with food for 56 days. Antipyrine is administered 1 hour prior to study drug on days 8, 22, and 35.
Part 2: Fifteen patients receive L-697,661 with food, for 8 weeks. Therapy with L-697,661 may be extended beyond 8 weeks for up to 24 weeks.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV infection.
- Patients in Part 1 must have received no previous zidovudine (AZT) or a stable dose of at least 500 mg/day without evidence of toxicity.
- Patients in Part 2 must have received no previous AZT or = or > 300 mg/day for < 6 consecutive weeks within 1 year prior to study entry.
Key exclusion criteria (24 listed)
- Acute HIV-related opportunistic infection requiring ongoing treatment.
- Diarrhea defined as 3 or more liquid stools/day for one week.
- Wilson's or Gilbert's disease, porphyria, or other chronic or acute hepatic disease.
- Potentially life-threatening allergic reactions to any of the components of zidovudine.
- Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study.
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 |
|---|---|---|
| L-697,661 | Drug | – |
| 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 30 Jul 2008.
- BackgroundKuritzkes DR, Curtis S, Rosandich M, Stein DS, Schooley RT. Delayed emergence of resistance to L-697,661 in patients receiving concomitant zidovudine. The ACTG 184 Study Team. Int Conf AIDS. 1993 Jun 6-11;9(1):467 (abstract no PO-B26-1994)
- Background: PubMed 8673545Schooley RT, Campbell TB, Kuritzkes DR, Blaschke T, Stein DS, Rosandich ME, Phair J, Pottage JC, Messari F, Collier A, Kahn J. Phase 1 study of combination therapy with L-697,661 and zidovudine. The ACTG 184 Protocol Team. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Aug 1;12(4):363-70. doi: 10.1097/00042560-199608010-00006.
- BackgroundCampbell TB, Routh JA, Bakhtiari M, Schooley RT, Kuritzkes DR. Detection of genotypic changes in reverse transcriptase during combination therapy with zidovudine and L-697,661. Detection of genotypic changes in reverse transcriptase during combination therapy with zidovudine and L-697,661. Int Conf AIDS. 1993 Jun 6-11;9(1):239 (abstract no PO-A26-0630)
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.
RT Schooley study chair
5 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 L-697,661 and Zidovudine in people with HIV Infections, run by Merck Sharp & Dohme LLC at 5 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 5 inclusion and 24 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 30 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 NCT00000628, which also lists 3 linked publications.
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 30 Jul 2008.