HIV InfectionsPhase 3NCT00007436
The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients
A Phase 3 study testing Tenofovir disoproxil fumarate in people with HIV Infections, run by Gilead Sciences at 19 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir disoproxil fumarate
- How many people
- Not given
- Where
- 19 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Have completed another study on tenofovir DF without toxicity.
- Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment.
Who cannot join
- Patients will not be eligible for this study if they:
- Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir.
- Are taking agents that affect kidney function, such as probenecid.
- Are receiving systemic chemotherapy.
- Are taking systemic corticosteroids.
- Are taking experimental drugs except those that are approved by Gilead.
- Are currently participating in the GS-99-908 or GS-00-912 (expanded access) studies.
- Are pregnant or breast-feeding.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
East Bay AIDS Ctr
Berkeley, California, 94705
CRI New England
Brookline, Massachusetts, 02146
Northstar Med Clinic
Chicago, Illinois, 60657
Southwest Infectious Diseases Associates
Dallas, Texas, 75246
Univ of Colorado / Health Science Ctr
Denver, Colorado, 80262
Hershey Med Ctr
Hershey, Pennsylvania, 17033
Thomas Street Clinic
Houston, Texas, 77009
Tower ID Med Associates
Los Angeles, California, 90048
Steinhart Medical Associates
Miami, Florida, 33133
Univ of Minnesota
Minneapolis, Minnesota, 55455
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15221
Research & Education Group
Portland, Oregon, 97209
Roger Williams Med Ctr
Providence, Rhode Island, 02908
Univ of Rochester Med Ctr
Rochester, New York, 14642
Pacific Horizons Med Group
San Francisco, California, 94115
Dr Philip C Craven
Tacoma, Washington, 98405
Harbor - UCLA Med Ctr
Torrance, California, 90502
Dr Gerald Pierone Jr
Vero Beach, Florida, 32960
Physicans Home Service
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.
Read the detailed description
Patients take tenofovir DF in combination with other antiretrovirals.
- Conditions
- HIV Infections
- Being tested
- Tenofovir disoproxil fumarate
- Keywords
- HIV-1, Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents, 9-(2-phosphonylmethoxypropyl)adenine
- 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 disoproxil fumarateDrug
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.
- 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 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007436
- Sponsor's protocol ID
- 283F
- Other IDs
- GS-99-910
- Status last verified
- Jul 2001
- First submitted
- 19 Dec 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 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00007436
- Acronym / sponsor ID
- 283F
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents, 9-(2-phosphonylmethoxypropyl)adenine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Gilead SciencesIndustry (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 this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.
Detailed description
Patients take tenofovir DF in combination with other antiretrovirals.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Have completed another study on tenofovir DF without toxicity.
- Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment.
Key exclusion criteria (8 listed)
- Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir.
- Are taking agents that affect kidney function, such as probenecid.
- Are receiving systemic chemotherapy.
- Are taking systemic corticosteroids.
- Are taking experimental drugs except those that are approved by Gilead.
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 disoproxil fumarate | 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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenofovir disoproxil fumarate in people with HIV Infections, run by Gilead Sciences at 19 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 3 inclusion and 8 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 19 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.