HIV InfectionsPhase 3NCT00002450
Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
A Phase 3 study testing Tenofovir disoproxil fumarate in people with HIV Infections, run by Gilead Sciences at 61 sites in 2 countries.
Trial summary
The purpose of this study is to see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective. 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 disoproxil fumarate
- How many people
- 600 participants
- Where
- 61 sitesin 2 countries
- 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 18 to 65 years
- 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.
- Have been on stable anti-HIV therapy for at least 8 weeks with no more than 4 anti-HIV drugs at the time of study entry.
- Have a viral load (level of HIV in the blood) between 400 and 10,000 copies/ml.
- Have good kidney function.
- Are 18 to 65 years old.
- Agree to use a barrier method of birth control (such as condoms) during the study and for 30 days after.
Who cannot join
- Patients will not be eligible for this study if they:
- Have a new AIDS-related illness diagnosed within 30 days of study entry.
- Have any other serious medical conditions, including kidney or bone disease, an active infection requiring antibiotics, or cancer (other than Kaposi's sarcoma or certain skin cancers).
- Have received a vaccine within 30 days of study entry.
- Are unable to take medications by mouth.
- Have ever taken tenofovir or adefovir dipivoxil.
Show all 9Show fewer
- Have taken certain medications within 30 days of study entry, such as chemotherapy, corticosteroids, medications that affect the kidneys, treatment for Kaposi's sarcoma, or certain experimental drugs.
- Abuse alcohol or drugs.
- Are pregnant or breast-feeding.
Trial locations and contacts
61 sites in 2 countries.
61 sites in 2 countries
United States58 sites
Albany Med College
Albany, New York, 12208
Univ of NM
Albuquerque, New Mexico, 87131
Infectious Diseases Physicians Inc
Annandale, Virginia, 22003
AIDS Research Consortium of Atlanta Inc
Atlanta, Georgia, 30308
Ponce de Leon Med Ctr
Atlanta, Georgia, 30308
Dr Joel Gallant
Baltimore, Maryland, 21205
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
New England Med Ctr
Boston, Massachusetts, 02111
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, 112123198
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207
Northstar Med Clinic
Chicago, Illinois, 60657
Ian Baird
Columbus, Ohio, 43214
Remington Davis Inc
Columbus, Ohio, 43215
Dallas Veterans Administration Med Ctr
Dallas, Texas, 75216
Nicholas Bellos
Dallas, Texas, 75246
Univ of Colorado / Health Science Ctr
Denver, Colorado, 80262
Harper Hosp
Detroit, Michigan, 48201
Therafirst Med Ctr
Fort Lauderdale, Florida, 33308
ARTCTC
Ft. Pierce, Florida, 34950
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Pennsylvania State College of Medicine
Hershey, Pennsylvania, 17033
Thomas Street Clinic
Houston, Texas, 77009
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030
Bendel Med Research
Lafayette, Louisiana, 70503
Ocean View Internal Medicine
Long Beach, California, 90803
St Mary's Med Ctr
Long Beach, California, 90813
AIDS Healthcare Foundation-Research Center
Los Angeles, California, 90027
Kaiser Permanente LAMC
Los Angeles, California, 90027
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, 90033
Cedars Sinai Med Ctr
Los Angeles, California, 90048
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, 90048
Steinhart Medical Associates
Miami, Florida, 33133
Univ of Miami School of Medicine
Miami, Florida, 33136
Yale New Haven Hosp / Nathan Smith Clinic
New Haven, Connecticut, 06504
Yale-New Haven Hospital
New Haven, Connecticut, 06504
Howard Grossman
New York, New York, 10011
St Vincent's Hosp
New York, New York, 10011
Columbia Univ
New York, New York, 10032
Robert Scott MD
Oakland, California, 94609
Oklahoma Univ Health Science Ctr
Oklahoma City, Oklahoma, 73104
Phoenix Body Positive
Phoenix, Arizona, 85016
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
Infections Ltd PS
Puyallup, Washington, 98371
Univ of Rochester Medical Center
Rochester, New York, 14642
Regions Hosp / HIV/AIDS Program
Saint Paul, Minnesota, 55101
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
UCSD Med Ctr - Owen Clinic
San Diego, California, 921038681
Pacific Horizons Med Group
San Francisco, California, 94115
Kaiser Foundation Hospital
San Francisco, California, 94118
San Francisco VA Med Ctr
San Francisco, California, 94121
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, 98405
Hillsborough County Health Dept
Tampa, Florida, 33602
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457
Harbor UCLA Med Ctr / Research and Educational Institute
Torrance, California, 90502
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Physicans Home Service
Washington D.C., District of Columbia, 20037
Puerto Rico3 sites
Ponce Univ Hosp
Ponce, 00731
Clinical Research Puerto Rico Inc
San Juan, 009091711
San Juan AIDS Program
Santurce, 00908
About this study
Official title: A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Tenofovir Disoproxil Fumarate in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
The purpose of this study is to see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective.
Read the detailed description
Patients are randomized 2:1 to add tenofovir DF once daily or placebo to their existing antiretroviral regimen in a blinded manner. Patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs taken prior to study entry. Patients and physicians are strongly discouraged from making changes in their antiviral therapies for at least 24 weeks post-randomization. After Week 24, changes in background antiretroviral therapy are permitted. At 24 weeks post-randomization, patients randomized to receive placebo are crossed over to receive open-label tenofovir DF once daily for the remainder of the 48-week study. While on study drug, patients are monitored for safety using periodic physical examinations and serial laboratory tests. Additionally, changes in plasma HIV RNA levels and CD4 cell counts are monitored to assess antiviral efficacy. At the end of the 48-week study period, patients are rolled over into extended dosing until tenofovir DF is commercially available or Gilead Sciences terminates the study.
- Conditions
- HIV Infections
- Being tested
- Tenofovir disoproxil fumarate
- Keywords
- HIV-1, Drug Therapy, Combination, Drug Administration Schedule, RNA, Viral, Anti-HIV Agents, Viral Load
- 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
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002450
- Sponsor's protocol ID
- 283D
- Other IDs
- GS-99-907
- Status last verified
- Jul 2000
- First submitted
- 17 Jan 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 III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Tenofovir Disoproxil Fumarate in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00002450
- Acronym / sponsor ID
- 283D
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, Drug Administration Schedule, RNA, Viral, Anti-HIV Agents, Viral Load
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- 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 see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective.
Detailed description
Patients are randomized 2:1 to add tenofovir DF once daily or placebo to their existing antiretroviral regimen in a blinded manner. Patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs taken prior to study entry. Patients and physicians are strongly discouraged from making changes in their antiviral therapies for at least 24 weeks post-randomization. After Week 24, changes in background antiretroviral therapy are permitted. At 24 weeks post-randomization, patients randomized to receive placebo are crossed over to receive open-label tenofovir DF once daily for the remainder of the 48-week study. While on study drug, patients are monitored for safety using periodic physical examinations and serial laboratory tests. Additionally, changes in plasma HIV RNA levels and CD4 cell counts are monitored to assess antiviral efficacy. At the end of the 48-week study period, patients are rolled over into extended dosing until tenofovir DF is commercially available or Gilead Sciences terminates the study.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are HIV-positive.
- Have been on stable anti-HIV therapy for at least 8 weeks with no more than 4 anti-HIV drugs at the time of study entry.
- Have a viral load (level of HIV in the blood) between 400 and 10,000 copies/ml.
- Have good kidney function.
- Are 18 to 65 years old.
Key exclusion criteria (9 listed)
- Have a new AIDS-related illness diagnosed within 30 days of study entry.
- Have any other serious medical conditions, including kidney or bone disease, an active infection requiring antibiotics, or cancer (other than Kaposi's sarcoma or certain skin cancers).
- Have received a vaccine within 30 days of study entry.
- Are unable to take medications by mouth.
- Have ever taken tenofovir or adefovir dipivoxil.
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
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 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.
61 sites in 2 countries: 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 61 sites in 2 countries.
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 7 inclusion and 9 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 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 61 sites in United States, Puerto Rico. 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?
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 24 Jun 2005.