HIV InfectionsPhase 2NCT00002415
Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
A Phase 2 study testing Tenofovir disoproxil fumarate in people with HIV Infections, run by Gilead Sciences at 24 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied. 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
- 175 participants
- Where
- 24 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 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
- You may be eligible for this study if you:
- Are HIV-positive.
- Have an HIV count of 400 - 50,000 copies/ml.
- Are expected to live for at least 1 year.
- Have been taking the same anti-HIV drug combination (made up of no more than 3 anti-HIV drugs) for at least 8 weeks prior to study entry.
- Are at least 18 years old.
- Agree to use effective methods of birth control during the study.
Who cannot join
- You will not be eligible for this study if you:
- Have taken medications for certain infections within 15 days prior to study entry.
- Have a history of cancer, except Kaposi's sarcoma (KS) or skin cancer.
- Develop a new AIDS-related condition within 30 days of study entry.
- Have certain serious medical conditions, including severe nausea, vomiting, or other stomach problems that make you unable to take medications by mouth.
- Have received a vaccine within 30 days prior to study entry.
Show all 9Show fewer
- Have taken certain medications, including those that may affect your kidneys.
- Abuse alcohol or drugs.
- Are pregnant.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
AIDS Research Consortium of Atlanta Inc
Atlanta, Georgia, 30308
Grady Mem Hosp
Atlanta, Georgia, 30308
Private Practice / Thacker and Thompson
Atlanta, Georgia, 30324
East Bay AIDS Ctr
Berkeley, California, 94705
Univ of Alabama at Birmingham / 1917 Rsch Cln
Birmingham, Alabama, 35294
CRI New England
Brookline, Massachusetts, 02445
Northstar Med Clinic
Chicago, Illinois, 60657
Univ Hosps of Cleveland
Cleveland, Ohio, 44106
Amelia Ct Clinic
Dallas, Texas, 75235
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Hershey Med Ctr
Hershey, Pennsylvania, 17033
Thomas Street Clinic
Houston, Texas, 77009
Tower Infectious Disease Med Ctr
Los Angeles, California, 90048
Univ of Minnesota
Minneapolis, Minnesota, 55455
Beth Israel Med Ctr
New York, New York, 10003
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, 10011
McDowell Clinic
Phoenix, Arizona, 85016
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213
The Research and Education Group
Portland, Oregon, 97210
Roger Williams Med Ctr
Providence, Rhode Island, 02908
UCSD Treatment Ctr
San Diego, California, 92103
San Francisco Veterans Adm Med Cntr
San Francisco, California, 94121
Hillsborough County Health Dept Special Care Ctr
Tampa, Florida, 33605
Harbor UCLA Med Ctr
Torrance, California, 90502
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Antiviral Activity of the Addition of PMPA Prodrug to Combination Antiretroviral Regimens in Treatment-Experienced HIV-Infected Patients
The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied.
Read the detailed description
Prior to study entry patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs. PMPA Prodrug or placebo is added to current antiretroviral regimens, and is administered in one of three dosing regimens. Patients randomized to receive placebo are eligible to receive open-label PMPA Prodrug for the remainder of the 48-week study period after at least 24 weeks post randomization.
- Conditions
- HIV Infections
- Being tested
- Tenofovir disoproxil fumarate
- Keywords
- Drug Therapy, Combination, Prodrugs, Anti-HIV Agents
- 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 175 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002415
- Sponsor's protocol ID
- 283B
- Other IDs
- GS-98-902
- Status last verified
- Nov 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Miller MD, Margot NA, Schooley R, McGowan I. Baseline and week 48 final phenotypic analysis of HIV-1 from patients adding tenofovir disoproxil fumarate (TDF) therapy to background ART. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 441)
Schooley R, Myers R, Ruane R, Beall G, Lampiris H, McGowan I. A double-blind, placebo-controlled study of tenofovir disoproxil fumarate (TDF) for the treatment of HIV infection. 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sep (abstract no I302I)
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 II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Antiviral Activity of the Addition of PMPA Prodrug to Combination Antiretroviral Regimens in Treatment-Experienced HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00002415
- Acronym / sponsor ID
- 283B
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Prodrugs, Anti-HIV Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 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 it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied.
Detailed description
Prior to study entry patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs. PMPA Prodrug or placebo is added to current antiretroviral regimens, and is administered in one of three dosing regimens. Patients randomized to receive placebo are eligible to receive open-label PMPA Prodrug for the remainder of the 48-week study period after at least 24 weeks post randomization.
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 an HIV count of 400 - 50,000 copies/ml.
- Are expected to live for at least 1 year.
- Have been taking the same anti-HIV drug combination (made up of no more than 3 anti-HIV drugs) for at least 8 weeks prior to study entry.
- Are at least 18 years old.
Key exclusion criteria (9 listed)
- Have taken medications for certain infections within 15 days prior to study entry.
- Have a history of cancer, except Kaposi's sarcoma (KS) or skin cancer.
- Develop a new AIDS-related condition within 30 days of study entry.
- Have certain serious medical conditions, including severe nausea, vomiting, or other stomach problems that make you unable to take medications by mouth.
- Have received a vaccine within 30 days prior to study entry.
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.
- BackgroundMiller MD, Margot NA, Schooley R, McGowan I. Baseline and week 48 final phenotypic analysis of HIV-1 from patients adding tenofovir disoproxil fumarate (TDF) therapy to background ART. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 441)
- BackgroundSchooley R, Myers R, Ruane R, Beall G, Lampiris H, McGowan I. A double-blind, placebo-controlled study of tenofovir disoproxil fumarate (TDF) for the treatment of HIV infection. 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sep (abstract no I302I)
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenofovir disoproxil fumarate in people with HIV Infections, run by Gilead Sciences at 24 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 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 24 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002415, which also lists 2 linked publications.
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.