HIV InfectionsPhase 2NCT00004985
Combination Treatment Using Capravirine (AG1549), Nelfinavir, and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy
A Phase 2 study testing Capravirine and Nelfinavir mesylate in people with HIV Infections, run by Agouron Pharmaceuticals at 34 sites in 2 countries.
Trial summary
The purpose of this study is to look at the effectiveness of an anti-HIV drug combination that adds capravirine in patients who have failed their first drug combination treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Capravirine and Nelfinavir mesylate
- How many people
- 75 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Jan 2000to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this trial if they:
- Are HIV-positive.
- Have a CD4 cell count more than 50/mm3.
- Are at least 18 years old.
- Have adequate blood, kidney, and liver functions.
- Are currently taking an anti-HIV drug combination of an NNRTI plus 1 or more NRTIs for more than 28 days and are failing that combination.
Who cannot join
- Patients will not be eligible for this trial if they:
- Have had any protease inhibitor or capravirine treatment.
- Have been given any drug that interferes with their immune system or with the study drugs within 28 days of study entry.
- Have had radiation therapy within 28 days of study entry.
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States33 sites
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Braude Mermin Spivey MD PC
Atlanta, Georgia, 30309
Central Texas Clinical Research
Austin, Texas, 78705
Pacific Oaks Med Group
Beverly Hills, California, 90211
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
Fenway Community Health Ctr
Boston, Massachusetts, 02115
Bach and Godofsky
Bradenton, Florida, 34205
Clin Research of West Florida
Clearwater, Florida, 33765
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
VAMC New Jersey Healthcare System
East Orange, New Jersey, 07018
Community Health Care
Fort Lauderdale, Florida, 33306
Therafirst Med Ctr
Fort Lauderdale, Florida, 33308
Univ TX Galveston Med Branch
Galveston, Texas, 77555
Biomedical Research Alliance of New York
Jamaica, New York, 11432
North Shore Univ Hosp
Manhasset, New York, 11030
South Shore Hosp
Miami, Florida, 33139
Immunity Care and Research Inc
Miami Beach, Florida, 33139
Jersey Shore Med Ctr
Neptune City, New Jersey, 07753
Liberty Medical
New York, New York, 10014
Mount Sinai Med Ctr
New York, New York, 10029
Orange County Health Dept
Orlando, Florida, 32805
First Choice Medical
Palm Springs, California, 92262
Phoenix Body Positive
Phoenix, Arizona, 85016
Apogee Med Group
San Diego, California, 92101
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, 94109
Kaiser Foundation Hospital
San Francisco, California, 94118
Infectious Diseases Associates
Sarasota, Florida, 34239
Infectious Disease Assoc of Central Jersey
Somerville, New Jersey, 08876
Hillsborough County Health Dept
Tampa, Florida, 33602
Harbor - UCLA Med Ctr
Torrance, California, 90502
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
Polk County Health Dept
Winter Haven, Florida, 33881
About this study
Official title: A Phase II, Single-Blind, Randomized, Placebo-Controlled Study of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Subjects Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen
The purpose of this study is to look at the effectiveness of an anti-HIV drug combination that adds capravirine in patients who have failed their first drug combination treatment.
Read the detailed description
[Note: As of 2/28/2001, due to toxicity studies and concern for safety, changes in the methodology were implemented and patients need to sign new informed consents. The study is unblinded. Group 1 receives AG1549; Group 2 receives an AG1549 placebo. Patients who are taking capravirine and who currently have viral loads below 400 copies/ml may continue to take capravirine at 1400 mg twice daily. Capravirine will be discontinued in patients with viral loads greater than 400 copies/ml at their last visit and they will be switched to new therapies or continue with their background therapies as deemed appropriate by the investigators.] Both groups also receive nelfinavir mesylate and 2 NRTIs. All patients receive the same dose of nelfinavir mesylate. The NRTIs are selected at the investigator's discretion provided the patient has not previously received the chosen NRTIs. Patients have regular physical examinations. Blood samples are collected regularly and at 1 month post-treatment to determine plasma HIV RNA, pharmacokinetics, and CD4 and CD8 counts. Patients who complete 24 weeks of treatment will have the option to continue treatment for an additional 24 weeks or end participation.
- Conditions
- HIV Infections
- Being tested
- Capravirine, Nelfinavir mesylate
- Keywords
- HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Nelfinavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapravirineDrug
Nelfinavir mesylateDrug
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)
- Study startJan 2000
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.
- 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
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Agouron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004985
- Sponsor's protocol ID
- 286D
- Other IDs
- AG1549-509
- Status last verified
- Mar 2001
- First submitted
- 15 Mar 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 II, Single-Blind, Randomized, Placebo-Controlled Study of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Subjects Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen
- ClinicalTrials.gov ID
- NCT00004985
- Acronym / sponsor ID
- 286D
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Nelfinavir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Agouron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- 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 look at the effectiveness of an anti-HIV drug combination that adds capravirine in patients who have failed their first drug combination treatment.
Detailed description
[Note: As of 2/28/2001, due to toxicity studies and concern for safety, changes in the methodology were implemented and patients need to sign new informed consents. The study is unblinded. Group 1 receives AG1549; Group 2 receives an AG1549 placebo. Patients who are taking capravirine and who currently have viral loads below 400 copies/ml may continue to take capravirine at 1400 mg twice daily. Capravirine will be discontinued in patients with viral loads greater than 400 copies/ml at their last visit and they will be switched to new therapies or continue with their background therapies as deemed appropriate by the investigators.] Both groups also receive nelfinavir mesylate and 2 NRTIs. All patients receive the same dose of nelfinavir mesylate. The NRTIs are selected at the investigator's discretion provided the patient has not previously received the chosen NRTIs. Patients have regular physical examinations. Blood samples are collected regularly and at 1 month post-treatment to determine plasma HIV RNA, pharmacokinetics, and CD4 and CD8 counts. Patients who complete 24 weeks of treatment will have the option to continue treatment for an additional 24 weeks or end participation.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are HIV-positive.
- Have a CD4 cell count more than 50/mm3.
- Are at least 18 years old.
- Have adequate blood, kidney, and liver functions.
- Are currently taking an anti-HIV drug combination of an NNRTI plus 1 or more NRTIs for more than 28 days and are failing that combination.
Key exclusion criteria (4 listed)
- Have had any protease inhibitor or capravirine treatment.
- Have been given any drug that interferes with their immune system or with the study drugs within 28 days of study entry.
- Have had radiation therapy within 28 days of 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 |
|---|---|---|
| Capravirine | Drug | – |
| Nelfinavir mesylate | 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
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.
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capravirine and Nelfinavir mesylate in people with HIV Infections, run by Agouron Pharmaceuticals at 34 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 6 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 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 34 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 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?
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.