HIV InfectionsPhase 1NCT00040300
A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males
A Phase 1 study testing Racivir in people with HIV Infections, run by Pharmasset.
Trial summary
The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Racivir
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Dec 2002
- 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 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects may be eligible to participate if they:
- Are males with HIV infection with a positive HIV antibody test
- Have an HIV-RNA copy number of ≥ 5000 copies/ml (Roche assay)
- Have CD4+ cell counts ≥ 50 cells/ml
- Are 18-45 years of age, inclusive
- Have a body mass index (BMI) ≥ 18 kg/m2
- Are antiretroviral nucleoside reverse transcriptase inhibitor-naive
- Have read and understand the informed consent,and is able and willing to comply with study procedures
Who cannot join
- Subjects may not participate if they:
- Have clinically significant ECG abnormalities
- Have clinically significant abnormalities in any safety laboratory parameters
- Have an ALT value ≥ 3xUNL
- Have previously participated in this trial
- Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug
Show all 11Show fewer
- Have a history of chronic alcohol or drug abuse within the last 6 months
- Have a positive urine drug screening
- Have a positive alcohol breath test
- Have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject's ability to participate in this trial
- Have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol
About this study
The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.
Read the detailed description
The study is a 14-day study with a 21-day follow-up period. During the 14-days of active study period, participants will receive Racivir once daily in combination with efavirenz and stavudine. Following the administration of the first and last dose of study medication, patients will remain in the clinic overnight. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, EKGs, and routine clinical laboratory tests.
- Conditions
- HIV Infections
- Being tested
- Racivir
- Keywords
- treatment experienced, HIV, Phase I, Combination Therapy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RacivirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2002 (estimated)
- Study startJun 2002
- Study completionDec 2002
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Pharmasset
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040300
- Sponsor's protocol ID
- CI-PSI-004-02-101
- Status last verified
- Jul 2005
- First submitted
- 24 Jun 2002
- Last updated
- 21 Jul 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males
- ClinicalTrials.gov ID
- NCT00040300
- Acronym / sponsor ID
- CI-PSI-004-02-101
- Conditions
- HIV Infections
- Keywords
- treatment experienced, HIV, Phase I, Combination Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- PharmassetIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Study completion
- Dec 2002
- First posted
- 25 Jun 2002 (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 evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.
Detailed description
The study is a 14-day study with a 21-day follow-up period. During the 14-days of active study period, participants will receive Racivir once daily in combination with efavirenz and stavudine. Following the administration of the first and last dose of study medication, patients will remain in the clinic overnight. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, EKGs, and routine clinical laboratory tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Are males with HIV infection with a positive HIV antibody test
- Have an HIV-RNA copy number of ≥ 5000 copies/ml (Roche assay)
- Have CD4+ cell counts ≥ 50 cells/ml
- Are 18-45 years of age, inclusive
- Have a body mass index (BMI) ≥ 18 kg/m2
Key exclusion criteria (11 listed)
- Have clinically significant ECG abnormalities
- Have clinically significant abnormalities in any safety laboratory parameters
- Have an ALT value ≥ 3xUNL
- Have previously participated in this trial
- Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug
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 |
|---|---|---|
| Racivir | 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 21 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Racivir in people with HIV Infections, run by Pharmasset.
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 8 inclusion and 11 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 21 Jul 2005. Status can change between updates, so confirm with the study contact before making plans.
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 21 Jul 2005.