HIV InfectionsPhase 2NCT00002357
The Safety and Effectiveness of HBY 097 Used With or Without AZT in HIV-Infected Patients Who Have Mild or No Symptoms
A Phase 2 study testing HBY 097 and Zidovudine in people with HIV Infections, run by Hoechst Marion Roussel at 6 sites in United States.
Trial summary
To obtain preliminary information on the safety, tolerability, and antiretroviral activity of HBY 097 alone or in combination with zidovudine ( AZT ) versus AZT alone. PER 1/19/96 AMENDMENT: AZT monotherapy arm was eliminated. 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?
- HBY 097 and Zidovudine
- How many people
- 144 participants
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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:
- Allowed:
- Treatment for opportunistic infection that develops on study.
- Recommended:
- PCP prophylaxis if CD4 count falls below 200 cells/mm3.
- Patients must have:
Show all 12Show fewer
- HIV infection.
- CD4 count 200 - 500 cells/mm3.
- HIV-1 RNA PCR value of 10000 copies/ml or higher.
- Asymptomatic or mildly symptomatic disease.
- No past or current AIDS-defining event.
- Consent of parent or guardian if less than legal age of consent.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Endocrine, hepatic, renal, or gastrointestinal disease.
- Cardiovascular conduction disease.
- Concomitant medical illness that may complicate study conduct or interpretation of results.
- Other factors that may interfere with patient compliance.
Show all 41Show fewer
- Concurrent Medication:
- Excluded:
- Antiretroviral agents other than study drugs.
- Oral contraceptives.
- Cytotoxic chemotherapy.
- Immunomodulators.
- Antiproliferative agents.
- Corticosteroids.
- Anabolic steroids.
- Estrogens.
- Quinoxaline derivatives.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following prior conditions are excluded:
- History of hypersensitivity to quinoxaline derivatives or intolerance to AZT.
- History of cardiovascular conduction disease.
- Prior participation in this study or any study using HBY 097.
- Recent use of a drug that interferes with drug metabolism, absorption, distribution, or excretion.
- History of thyroid disease.
- Prior Medication:
- Excluded at any time:
- Prior non-nucleoside reverse transcriptase inhibitors.
- Excluded within 30 days prior to study entry:
- Any antiretroviral therapy.
- Oral contraceptives.
- Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons.
- Cytotoxic chemotherapeutic agents.
- Other investigational drugs.
- Excluded within 6 months prior to study entry:
- Immunotherapeutic vaccine.
- Prior Treatment:
- Excluded within 30 days prior to study entry:
- Radiation therapy.
- An experimental device. Current ethanol or illicit drug abuse.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Med College of Georgia
Augusta, Georgia, 30912
Houston Clinical Research Network
Houston, Texas, 77006
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
New York Univ Med Ctr
New York, New York, 10016
Stanford Univ School of Medicine
Stanford, California, 943055107
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
About this study
Official title: A Multicenter, Randomized, Double-Blinded, Dose-Escalation Study Evaluating the Safety and Antiretroviral Activity of HBY 097 Versus HBY 097 Plus AZT in Patients With Asymptomatic or Mildly Symptomatic HIV Infection
To obtain preliminary information on the safety, tolerability, and antiretroviral activity of HBY 097 alone or in combination with zidovudine ( AZT ) versus AZT alone.
PER 1/19/96 AMENDMENT: AZT monotherapy arm was eliminated.
Read the detailed description
Patients are randomized to receive one of three doses of HBY 097 with or without AZT or AZT alone for 12 weeks (AZT monotherapy arm eliminated per 1/19/96 amendment). All patients at a given dose level of HBY 097 must be enrolled and adequate safety data obtained before escalation in subsequent patients begins. Additional patients are entered at the optimal dose of HBY 097. Patients are evaluated weekly for the first 4 weeks and then every 2 weeks for the next 9 weeks.
PER AMENDMENT: Enrollment to the lowest dose cohort is completed.
- Conditions
- HIV Infections
- Being tested
- HBY 097, Zidovudine
- Keywords
- Drug Therapy, Combination, AIDS-Related Complex, Antiviral Agents, Zidovudine
- Medical subject headings
- HIV Infections, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBY 097Drug
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 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 144 participants
Sponsor and investigators
- Lead sponsor
- Hoechst Marion Roussel
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002357
- Sponsor's protocol ID
- 252A
- Other IDs
- HBY097/2001
- Status last verified
- May 1997
- 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 Multicenter, Randomized, Double-Blinded, Dose-Escalation Study Evaluating the Safety and Antiretroviral Activity of HBY 097 Versus HBY 097 Plus AZT in Patients With Asymptomatic or Mildly Symptomatic HIV Infection
- ClinicalTrials.gov ID
- NCT00002357
- Acronym / sponsor ID
- 252A
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, AIDS-Related Complex, Antiviral Agents, Zidovudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants
- Lead sponsor
- Hoechst Marion RousselIndustry (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 obtain preliminary information on the safety, tolerability, and antiretroviral activity of HBY 097 alone or in combination with zidovudine ( AZT ) versus AZT alone.
PER 1/19/96 AMENDMENT: AZT monotherapy arm was eliminated.
Detailed description
Patients are randomized to receive one of three doses of HBY 097 with or without AZT or AZT alone for 12 weeks (AZT monotherapy arm eliminated per 1/19/96 amendment). All patients at a given dose level of HBY 097 must be enrolled and adequate safety data obtained before escalation in subsequent patients begins. Additional patients are entered at the optimal dose of HBY 097. Patients are evaluated weekly for the first 4 weeks and then every 2 weeks for the next 9 weeks.
PER AMENDMENT: Enrollment to the lowest dose cohort is completed.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Treatment for opportunistic infection that develops on study.
- PCP prophylaxis if CD4 count falls below 200 cells/mm3.
- HIV infection.
- CD4 count 200 - 500 cells/mm3.
- HIV-1 RNA PCR value of 10000 copies/ml or higher.
Key exclusion criteria (41 listed)
- Endocrine, hepatic, renal, or gastrointestinal disease.
- Cardiovascular conduction disease.
- Concomitant medical illness that may complicate study conduct or interpretation of results.
- Other factors that may interfere with patient compliance.
- Antiretroviral agents other than study drugs.
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 |
|---|---|---|
| HBY 097 | 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 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HBY 097 and Zidovudine in people with HIV Infections, run by Hoechst Marion Roussel at 6 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 12 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 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.