HIV InfectionsPhase 1NCT00005120
The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
A Phase 1 study testing Calanolide A in people with HIV Infections, run by Sarawak MediChem Pharmaceuticals at 7 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past. 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?
- Calanolide A
- How many people
- 16 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2000to 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 at least 18 years old.
- Agree to use effective methods of birth control during the study.
- Have a CD4 cell count of 200 cells/mm3 or more.
- Have HIV levels of 5000 copies/ml or more.
Who cannot join
- Patients will not be eligible for this study if they:
- Have abnormal blood tests.
- Have had a reaction to study medication.
- Have a history of opportunistic (AIDS-related) infection or cancer.
- Are being treated for active pulmonary tuberculosis.
- Have a fever of 39 degrees C or more within 14 days of beginning study treatment.
Show all 16Show fewer
- Are unable to take medications by mouth.
- Have an abnormal chest X-ray or ECG within 30 days of beginning study treatment.
- Have hepatitis, hemophilia, or other blood disorder.
- Have significant heart, stomach, intestinal, liver, nerve, or kidney problems.
- Have a condition which may affect ability to participate in this study, such as drug or alcohol abuse or a serious mental disorder.
- Have taken anti-HIV drugs in the past.
- Are taking certain medications.
- Have had a blood transfusion within the 3 months prior to entering the study.
- Have had radiation or chemotherapy within 16 days before the screening visit or plan to receive such treatment during the study.
- Are pregnant or breast-feeding.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
The CORE Ctr
Chicago, Illinois, 60612
Burnside Clinic
Columbia, South Carolina, 29206
Univ of Texas Med Branch
Galveston, Texas, 775550835
South Florida Bioavailability Clinic
Miami, Florida, 331813405
Anderson Clinical Research
Philadelphia, Pennsylvania, 19107
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15221
About this study
Official title: A Phase IB Study to Evaluate the Safety, Pharmacokinetics, and Effects of (+)-Calanolide A on Surrogate Markers in HIV-Positive Patients With No Previous Antiretroviral Therapy
The purpose of this study is to see if it is safe and effective to give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past.
Read the detailed description
Patients are randomized to receive (+)-calanolide A or placebo for 21 days. All patients may elect to receive an open-label, 3-month course of approved retroviral therapy (up to triple-drug therapy) to be selected by, and administered under the care of, the patients' physicians. If the patient has no insurance coverage or does not wish to utilize his/her insurance for anti-HIV medications, Sarawak MediChem Pharmaceuticals will provide these medications at no charge for up to 3 months.
- Conditions
- HIV Infections
- Being tested
- Calanolide A
- Keywords
- CD4 Lymphocyte Count, Biological Markers, Anti-HIV Agents, Viral Load, Pharmacokinetics, calanolide A
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calanolide ADrug
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 startApr 2000
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
- 16 participants
Sponsor and investigators
- Lead sponsor
- Sarawak MediChem Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005120
- Sponsor's protocol ID
- 297B
- Other IDs
- 57CL-0001
- Status last verified
- Jun 2001
- First submitted
- 20 Apr 2000
- 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 IB Study to Evaluate the Safety, Pharmacokinetics, and Effects of (+)-Calanolide A on Surrogate Markers in HIV-Positive Patients With No Previous Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00005120
- Acronym / sponsor ID
- 297B
- Conditions
- HIV Infections
- Keywords
- CD4 Lymphocyte Count, Biological Markers, Anti-HIV Agents, Viral Load, Pharmacokinetics, calanolide A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants
- Lead sponsor
- Sarawak MediChem PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- 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 this study is to see if it is safe and effective to give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past.
Detailed description
Patients are randomized to receive (+)-calanolide A or placebo for 21 days. All patients may elect to receive an open-label, 3-month course of approved retroviral therapy (up to triple-drug therapy) to be selected by, and administered under the care of, the patients' physicians. If the patient has no insurance coverage or does not wish to utilize his/her insurance for anti-HIV medications, Sarawak MediChem Pharmaceuticals will provide these medications at no charge for up to 3 months.
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 (5 listed)
- Are at least 18 years old.
- Agree to use effective methods of birth control during the study.
- Have a CD4 cell count of 200 cells/mm3 or more.
- Have HIV levels of 5000 copies/ml or more.
Key exclusion criteria (16 listed)
- Have abnormal blood tests.
- Have had a reaction to study medication.
- Have a history of opportunistic (AIDS-related) infection or cancer.
- Are being treated for active pulmonary tuberculosis.
- Have a fever of 39 degrees C or more within 14 days of beginning study treatment.
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 |
|---|---|---|
| Calanolide A | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
7 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 Calanolide A in people with HIV Infections, run by Sarawak MediChem Pharmaceuticals at 7 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 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: status not confirmed, 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 7 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?
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 24 Jun 2005.