HIV InfectionsNCT00002161
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3
A study testing Adefovir dipivoxil in people with HIV Infections, run by Gilead Sciences at 27 sites in United States.
Trial summary
To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Adefovir dipivoxil
- How many people
- 400 participants
- Where
- 27 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- HIV infection with HIV RNA titer >= 2500 copies/ml (2.5 KEq/ml) plasma.
- CD4 count >= 200 cells/mm3.
- No new AIDS-defining event within the past 2 months.
- Life expectancy at least 1 year.
- Consent of parent or guardian if less than 18 years old.
Show all 9Show fewer
- Tolerated antiretroviral therapy for the past 2 months.
- NOTE:
- Kaposi's sarcoma is permitted provided patient has not received systemic therapy within the past month.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Active, serious infections other than HIV that require parenteral antibiotic or antiviral therapy.
- Gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would preclude oral medication.
- Malignancy other than Kaposi's sarcoma or basal cell carcinoma.
- Concurrent Medication:
Show all 21Show fewer
- Excluded:
- Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
- Isoniazid.
- Rifampin.
- Investigational agents (unless approved by sponsor).
- Systemic chemotherapeutic agents.
- Prior Medication:
- Excluded:
- Parenteral antibiotic or antiviral therapy for another active, serious infection within the past 2 weeks.
- Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons within the past month.
- Systemic therapy for KS within the past month.
- Required:
- Antiretroviral regimen other than study drug.
- Required:
- Antiretroviral therapy for at least the past 2 months. Current alcohol or substance abuse that would interfere with compliance.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Albany Med College / Clinical Pharmacy Studies
Albany, New York, 12208
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 303081962
East Bay AIDS Ctr
Berkeley, California, 94705
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Harvard Univ / Massachusetts Gen Hosp
Boston, Massachusetts, 02114
Carolinas Med Ctr
Charlotte, North Carolina, 28204
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
Northwestern Univ Med Ctr
Chicago, Illinois, 60611
Dallas VA Med Ctr
Dallas, Texas, 75216
Wayne State Univ / Univ Health Ctr
Detroit, Michigan, 48201
Univ of Texas
Galveston, Texas, 77555
Houston Clinical Research Network
Houston, Texas, 77004
Kraus Med Partners
Los Angeles, California, 90509
Univ of Wisconsin
Madison, Wisconsin, 53792
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37212
Tulane Univ / Tulane / LSU Clinical Trials Unit
New Orleans, Louisiana, 70122
Saint Vincent's Med Ctr
New York, New York, 10011
The Research and Education Group
Portland, Oregon, 97210
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
San Francisco Gen Hosp
San Francisco, California, 94115
Santa Clara Valley Med Ctr
San Jose, California, 951282699
San Mateo County Med Ctr / San Mateo County AIDS Prog
San Mateo, California, 94403
Pacific Oaks Research
Sherman Oaks, California, 91403
Univ of South Florida
St. Petersburg, Florida, 33705
Harbor UCLA Med Ctr
Torrance, California, 90502
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Institute for Clinical Research
Washington D.C., District of Columbia, 20422
About this study
To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.
Read the detailed description
Patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks, after which all patients will receive open-label drug for an additional 24 weeks. Study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks. Patients are followed every 4 weeks during the first 24 weeks of study, then every 8 weeks during the last 24 weeks.
- Conditions
- HIV Infections
- Being tested
- Adefovir dipivoxil
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adefovir dipivoxilDrug
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 N/A
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002161
- Sponsor's protocol ID
- 232C
- Other IDs
- GS-96-408
- Status last verified
- May 1997
- First submitted
- 2 Nov 1999
- 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 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3
- ClinicalTrials.gov ID
- NCT00002161
- Acronym / sponsor ID
- 232C
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 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.
To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.
Detailed description
Patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks, after which all patients will receive open-label drug for an additional 24 weeks. Study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks. Patients are followed every 4 weeks during the first 24 weeks of study, then every 8 weeks during the last 24 weeks.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- HIV infection with HIV RNA titer >= 2500 copies/ml (2.5 KEq/ml) plasma.
- CD4 count >= 200 cells/mm3.
- No new AIDS-defining event within the past 2 months.
- Life expectancy at least 1 year.
- Consent of parent or guardian if less than 18 years old.
Key exclusion criteria (21 listed)
- Active, serious infections other than HIV that require parenteral antibiotic or antiviral therapy.
- Gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would preclude oral medication.
- Malignancy other than Kaposi's sarcoma or basal cell carcinoma.
- Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
- Isoniazid.
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 |
|---|---|---|
| Adefovir dipivoxil | 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.
Related trials for HIV Infections
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adefovir dipivoxil in people with HIV Infections, run by Gilead Sciences at 27 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 21 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 27 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.
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.