HIV InfectionsPhase 1NCT00016692
Safety and Tolerability of Z-100 in Patients With Early HIV Infection
A Phase 1 study testing Z-100 in people with HIV Infections, run by Zeria Pharmaceutical at 3 sites in United States.
Trial summary
The purpose of the study is to see if Z-100 (an investigational drug) treatment is safe in HIV patients who have never received treatment for their HIV, who have not been taking highly active antiretroviral therapy (HAART) for at least 8 weeks, or who have been stable on their current first or second HAART regimen for… 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?
- Z-100
- How many people
- Not given
- Where
- 3 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 may be eligible for this study if they:
- Are HIV positive but do not show symptoms.
- Are male or female, 18 years or older.
- Have not received treatment for HIV.
- Have received treatment but have discontinued HAART for at least 8 weeks prior to screening, have had stable viral loads on at least 2 separate time points at least 1 month apart including screening, and have had stable CD4 levels on at least 2 separate time points at least 1 month apart including screening.
- Use birth control while on the study and during the follow-up period.
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- Have viral loads of 2,000 to 55,000 copies/ml within 2 weeks of randomization.
- Have CD4 counts of greater than 350 cells/mm within 2 weeks of randomization.
- Have a negative serum pregnancy test within 2 weeks of randomization (women able to have children).
Who cannot join
- Patients will not be eligible for this study if they:
- Have failed HAART treatment.
- Have opportunistic infection or cancer.
- Have a history of tuberculosis.
- Have very abnormal laboratory test results.
- Have heart, liver, kidney or nervous system conditions.
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- Have serious problems digesting and absorbing food or have serious long-term diarrhea within 4
- weeks of randomization.
- Have received radiation (localized is allowed) or chemotherapy within 30 days before randomization.
- Have seizure disorders that cannot be controlled.
- Have received any other drugs that affect the immune system or experimental drugs within 60 days before randomization.
- Have had any vaccination within 15 days before randomization.
- Have a mental condition which makes the patient unable to understand what the study is about and what it involves.
- Have a history of alcohol or drug abuse, unless the investigator feels that it will not interfere with participation in the protocol.
- Are pregnant or breast-feeding.
- Have a history of being very sensitive to the study drug or similar drugs.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern Univ Med School
Chicago, Illinois, 60611
Univ TX Med Branch
Galveston, Texas, 77555
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
About this study
Official title: A Phase 1b Multicenter Double-Blind, Placebo-Controlled, Randomized Study on the Safety and Tolerability of Z-100 in Early HIV-1 Infected Patients
The purpose of the study is to see if Z-100 (an investigational drug) treatment is safe in HIV patients who have never received treatment for their HIV, who have not been taking highly active antiretroviral therapy (HAART) for at least 8 weeks, or who have been stable on their current first or second HAART regimen for at least 12 weeks.
- Conditions
- HIV Infections
- Being tested
- Z-100
- Keywords
- Drug tolerance, Acute Infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-100Drug
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 1
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016692
- Sponsor's protocol ID
- B014
- Other IDs
- Zeria Protocol 85D10104
- Status last verified
- Apr 2001
- First submitted
- 24 May 2001
- Last updated
- 27 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Multicenter Double-Blind, Placebo-Controlled, Randomized Study on the Safety and Tolerability of Z-100 in Early HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00016692
- Acronym / sponsor ID
- B014
- Conditions
- HIV Infections
- Keywords
- Drug tolerance, Acute Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Zeria PharmaceuticalIndustry (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.
The purpose of the study is to see if Z-100 (an investigational drug) treatment is safe in HIV patients who have never received treatment for their HIV, who have not been taking highly active antiretroviral therapy (HAART) for at least 8 weeks, or who have been stable on their current first or second HAART regimen for at least 12 weeks.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Are HIV positive but do not show symptoms.
- Are male or female, 18 years or older.
- Have not received treatment for HIV.
- Have received treatment but have discontinued HAART for at least 8 weeks prior to screening, have had stable viral loads on at least 2 separate time points at least 1 month apart including screening, and have had stable CD4 levels on at least 2 separate time points at least 1 month apart including screening.
- Use birth control while on the study and during the follow-up period.
Key exclusion criteria (16 listed)
- Have failed HAART treatment.
- Have opportunistic infection or cancer.
- Have a history of tuberculosis.
- Have very abnormal laboratory test results.
- Have heart, liver, kidney or nervous system conditions.
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 |
|---|---|---|
| Z-100 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2006.
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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.
3 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 Z-100 in people with HIV Infections, run by Zeria Pharmaceutical at 3 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 9 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: stopped early, as of the sponsor's last update on 27 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early. Results are not available in the source record.
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 27 Apr 2006.