HIV InfectionsPhase 4NCT00005106
A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients
A Phase 4 study testing Lamivudine/Zidovudine, Abacavir sulfate and Nelfinavir mesylate in people with HIV Infections, run by Glaxo Wellcome at 39 sites in United States.
Trial summary
The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before. 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?
- Lamivudine/Zidovudine, Abacavir sulfate and Nelfinavir mesylate
- How many people
- 230 participants
- Where
- 39 sitesUnited States
- Study dates
- Sep 1999to not given
- Phase
- Phase 4
- 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 study if they:
- Are at least 18 years old.
- Are HIV-positive.
- Have a CD4 count greater than 50 cells/mm3.
- Have a viral load greater than 1,000 copies/ml but less than 200,000 copies/ml.
- Have never received anti-HIV medications before. (However, less than 1 week of therapy with lamivudine or a protease inhibitor and less than 4 weeks of therapy with other nucleoside reverse transcriptase inhibitors [NRTIs] is allowed. No therapy with nonnucleoside reverse transcriptase inhibitors [NNRTIs] is allowed.)
- Cannot bear children or agree to use effective methods of birth control during the study. Hormonal methods of birth control (such as birth control pills) are not considered effective for this study.
Who cannot join
- Patients will not be eligible for this study if they:
- Have an active AIDS-defining opportunistic infection or disease that, in the doctor's opinion, would make them unable to participate.
- Are unable, in the opinion of the doctor, to follow the dosing schedule and follow-up visit schedule.
- Have a substance abuse problem that would interfere with taking the medications correctly or attending the clinic visits.
- Are enrolled in another study.
- Cannot take medications by mouth or absorb drugs.
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- Have hepatitis.
- Have a serious medical condition such as diabetes, congestive heart failure, or other heart disease.
- Need chemotherapy or radiation therapy (except for local treatment of Kaposi's sarcoma).
- Are taking certain medications.
- Are pregnant or breast-feeding.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Summa Health System
Akron, Ohio, 44304
IDC Research Initiative
Altamonte Springs, Florida, 32701
WNC Community Health Services
Asheville, North Carolina, 28806
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Ponce de Leon Ctr
Atlanta, Georgia, 30308
Philip Brachman
Atlanta, Georgia, 30309
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942050
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
Carolinas Med Ctr
Charlotte, North Carolina, 28232
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Cook County Hosp
Chicago, Illinois, 60614
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75235
Children's Diagnostic Treatment Ctr
Fort Lauderdale, Florida, 33301
Community Health Care
Fort Lauderdale, Florida, 33306
Comprehensive Care Center
Fort Lauderdale, Florida, 33316
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Thomas Street Clinic
Houston, Texas, 77009
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
Longbeach Memorial Med Ctr
Longbeach, California, 90806
Good Samaritan Hosp
Los Angeles, California, 90004
THE Clinic
Los Angeles, California, 90008
AIDS Healthcare Foundation
Los Angeles, California, 900276069
Maxine Liggins
Los Angeles, California, 90042
UCLA Care Ctr
Los Angeles, California, 90095
Univ of Miami School of Medicine
Miami, Florida, 33136
South Shore Hosp
Miami, Florida, 33139
HIV Outpatient Clinics / LA State Univ Med Ctr
New Orleans, Louisiana, 70112
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
Orange County Health Dept
Orlando, Florida, 32805
MCP Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102
Immunity Care and Research Inc
Plantation, Florida, 33324
Miriam Hosp
Providence, Rhode Island, 02906
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 782847881
San Francisco Gen Hosp
San Francisco, California, 94110
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244
Daniel Seekins
Tampa, Florida, 33607
Infectious Disease Research Institute
Tampa, Florida, 33614
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
About this study
Official title: A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250mg BID) Versus Abacavir (300mg BID) Plus Combivir (3TC 150mg/ZDV 300mg BID) Versus Combivir (3TC 150mg/ZDV 300mg BID) Plus Nelfinavir (1250mg BID) in HIV-1 Infected Subjects
The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.
Read the detailed description
Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.
- Conditions
- HIV Infections
- Being tested
- Lamivudine/Zidovudine, Abacavir sulfate, Nelfinavir mesylate, Lamivudine, Stavudine
- Keywords
- Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Adipose Tissue, Lipodystrophy, abacavir
- Medical subject headings
- HIV Infections, Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine/ZidovudineDrug
Abacavir sulfateDrug
Nelfinavir mesylateDrug
LamivudineDrug
StavudineDrug
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 startSep 1999
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 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 230 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005106
- Sponsor's protocol ID
- 264P
- Other IDs
- ESS40002
- Status last verified
- Nov 2000
- First submitted
- 6 Apr 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 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250mg BID) Versus Abacavir (300mg BID) Plus Combivir (3TC 150mg/ZDV 300mg BID) Versus Combivir (3TC 150mg/ZDV 300mg BID) Plus Nelfinavir (1250mg BID) in HIV-1 Infected Subjects
- ClinicalTrials.gov ID
- NCT00005106
- Acronym / sponsor ID
- 264P
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- Study start
- Sep 1999
- 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 effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.
Detailed description
Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are at least 18 years old.
- Are HIV-positive.
- Have a CD4 count greater than 50 cells/mm3.
- Have a viral load greater than 1,000 copies/ml but less than 200,000 copies/ml.
- Have never received anti-HIV medications before. (However, less than 1 week of therapy with lamivudine or a protease inhibitor and less than 4 weeks of therapy with other nucleoside reverse transcriptase inhibitors [NRTIs] is allowed. No therapy with nonnucleoside reverse transcriptase inhibitors [NNRTIs] is allowed.)
Key exclusion criteria (11 listed)
- Have an active AIDS-defining opportunistic infection or disease that, in the doctor's opinion, would make them unable to participate.
- Are unable, in the opinion of the doctor, to follow the dosing schedule and follow-up visit schedule.
- Have a substance abuse problem that would interfere with taking the medications correctly or attending the clinic visits.
- Are enrolled in another study.
- Cannot take medications by mouth or absorb drugs.
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 |
|---|---|---|
| Lamivudine/Zidovudine | Drug | – |
| Abacavir sulfate | Drug | – |
| Nelfinavir mesylate | Drug | – |
| Lamivudine | Drug | – |
| Stavudine | 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.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lamivudine/Zidovudine, Abacavir sulfate and Nelfinavir mesylate in people with HIV Infections, run by Glaxo Wellcome at 39 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 11 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 39 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.