HIV InfectionsPhase 1/2NCT00036634
A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients
A Phase 1/2 study testing Tenofovir DF and Tenofovir alafenamide in people with HIV Infections, run by Gilead Sciences at 3 sites in United States.
Trial summary
This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir DF and Tenofovir alafenamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2002to Feb 2003
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 RNA levels greater than or equal to 30,000 copies/mL
- CD4 count greater than or equal to 200 cells/mm3
- Serum creatinine <1.5 mg/dl
- Hepatic transaminases less than or equal to 2.5 times the upper limit of normal
- Total bilirubin less than or equal to 1.5 mg/dL
- Adequate hematologic function
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- Serum amylase less than or equal to 1.5 times the upper limit of normal
- Serum phosphate greater than or equal to 2.2 mg/dL
- Not pregnant
Who cannot join
- Prior treatment with antiretroviral therapy
- Immunization within 30 days of study entry
- A new AIDS defining condition within 30 days of study entry
- Receiving nephrotoxic agents, probenecid, chemotherapeutic agents, corticosteroids, interleukin-2
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Protocare Trials Chicago Center for Clinical Trials
Chicago, Illinois, 60610
Rockefeller University Hospital
New York, New York, 10021
Stanford Positive Care Program
Palo Alto, California, 94304
About this study
Official title: A Phase 1/2, Randomized, Double-Blind, Active Controlled, Dose Escalation Study of the Safety, Tolerance, Pharmacokinetic,, and Antiviral Activity of GS-7340-02 in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1
This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).
- Conditions
- HIV Infections
- Being tested
- Tenofovir DF, Tenofovir alafenamide
- Keywords
- treatment naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir DFDrug
Also called Viread®
Tenofovir DF tablet administered orally once daily
Tenofovir alafenamideDrug
Also called GS-7340
Tenofovir alafenamide tablet(s) administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir DF | Active comparator | Participants received tenofovir DF 300 mg for 14 days Receives: Drug: Tenofovir DF |
| Tenofovir alafenamide 50 mg | Experimental | Participants received tenofovir alafenamide 50 mg for 14 days Receives: Drug: Tenofovir alafenamide |
| Tenofovir alafenamide 150 mg | Experimental | Participants received tenofovir alafenamide 150 mg for 14 days Receives: Drug: Tenofovir alafenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL)
DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.
Measured: Baseline to Week 2
Secondary outcomes (2)
Change from baseline in HIV-1 RNA (log10 copies/mL)
Measured: Baseline to Week 2
Change from baseline in CD4 cell count (cells/mm3)
Measured: Baseline to Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2002 (estimated)
- Study startMar 2002
- Primary completionFeb 2003
- Study completionFeb 2003
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.
- More trials run by Gilead SciencesThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036634
- Sponsor's protocol ID
- GS-120-1101
- Status last verified
- Jan 2014
- First submitted
- 13 May 2002
- Last updated
- 15 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Double-Blind, Active Controlled, Dose Escalation Study of the Safety, Tolerance, Pharmacokinetic,, and Antiviral Activity of GS-7340-02 in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1
- ClinicalTrials.gov ID
- NCT00036634
- Acronym / sponsor ID
- GS-120-1101
- Conditions
- HIV Infections
- Keywords
- treatment naive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 14 May 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.
This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tenofovir DF | Active comparator | Drug: Tenofovir DFParticipants received tenofovir DF 300 mg for 14 days |
| Tenofovir alafenamide 50 mg | Experimental | Drug: Tenofovir alafenamideParticipants received tenofovir alafenamide 50 mg for 14 days |
| Tenofovir alafenamide 150 mg | Experimental | Drug: Tenofovir alafenamideParticipants received tenofovir alafenamide 150 mg for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HIV-1 RNA levels greater than or equal to 30,000 copies/mL
- CD4 count greater than or equal to 200 cells/mm3
- Serum creatinine <1.5 mg/dl
- Hepatic transaminases less than or equal to 2.5 times the upper limit of normal
- Total bilirubin less than or equal to 1.5 mg/dL
Key exclusion criteria (4 listed)
- Prior treatment with antiretroviral therapy
- Immunization within 30 days of study entry
- A new AIDS defining condition within 30 days of study entry
- Receiving nephrotoxic agents, probenecid, chemotherapeutic agents, corticosteroids, interleukin-2
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 |
|---|---|---|
| Tenofovir DFAlso: Viread®Tenofovir DF tablet administered orally once daily | Drug | Tenofovir DF |
| Tenofovir alafenamideAlso: GS-7340Tenofovir alafenamide tablet(s) administered orally once daily | Drug | Tenofovir alafenamide 150 mg, Tenofovir alafenamide 50 mg |
Primary outcome
Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL)
Time frame: Baseline to Week 2
DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.
2 secondary outcomes
Change from baseline in HIV-1 RNA (log10 copies/mL)
Time frame: Baseline to Week 2
Change from baseline in CD4 cell count (cells/mm3)
Time frame: Baseline to Week 2
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 15 Jan 2014.
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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 1/2 study testing Tenofovir DF and Tenofovir alafenamide in people with HIV Infections, run by Gilead Sciences 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 4 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 15 Jan 2014. 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 combined 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.
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.
What does the primary outcome measure?
Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL) (time frame: Baseline to Week 2). It is what the study was designed to measure, not a finding.
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 15 Jan 2014.