HIV InfectionsPhase 4NCT00005764
A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
A Phase 4 study testing Lamivudine/Zidovudine, Abacavir sulfate and Lamivudine in people with HIV Infections and Lipodystrophy, run by Glaxo Wellcome at 31 sites in United States.
Trial summary
The purpose of this study is to see if the findings of increased lactic acid and abnormal fat distribution get better when d4T is replaced with abacavir, abacavir plus lamivudine, or Combivir (a pill containing lamivudine plus zidovudine) in HIV-positive patients taking anti-HIV therapy including stavudine (d4T). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Lipodystrophy
- What is being tested?
- Lamivudine/Zidovudine, Abacavir sulfate and Lamivudine
- How many people
- 100 participants
- Where
- 31 sitesUnited States
- Study dates
- May 2000to 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 HIV-positive.
- Are at least 18 years old.
- Agree not to have intercourse 2 weeks before, during, and 2 weeks after study or agree to use effective methods of birth control.
- Have had HIV-1 RNA levels less than 400 copies/ml on the 2 most recent measurements.
- Have at least 1 of the following situations:
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- (a) at least 1 of the following: (1) decrease in facial fat, (2) decrease in fat in lower limbs, or (3) decrease in fat in buttocks area; or
- (b) an increase in lactate level greater than 2.2 mmol/L at the screening visit plus at least 1 of the following: (1) decrease in facial fat, (2) decrease in fat in lower limbs, or (3) decrease in fat in the buttocks area; or
- (c) an increase in lactate level greater than 2.2 mmol/L at screening visit plus at least 2 of the following: (1) shortness of breath, (2) weakness, (3) fast heartbeat, (4) recent weight loss (10 lbs. within the past 2 months), (5) pain and/or bloating in the abdomen, (6) nausea and/or vomiting and/or lack of appetite; or
- (d) lactate level greater than 3.2 mmol/L at the screening visit.
- Are able to read at a sixth-grade level.
- Have taken d4T consistently for the 6 months before entering study.
Who cannot join
- Patients will not be eligible for this study if they:
- Have diabetes or kidney failure.
- Have any condition that makes them unable to participate in this study.
- Are unable to take medications by mouth.
- Have serious medical conditions, such as congestive heart failure or other heart disease, which would affect the safety of the patient.
- Are taking or have taken abacavir plus Retrovir or Combivir.
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- Are pregnant or breast-feeding.
- Are enrolled in other clinical studies.
- Have had a reaction to or are unable to take abacavir and have taken Retrovir in the past.
- Have taken hydroxyurea within the past 3 days or plan to take this drug during the study.
- Have had chemotherapy or radiation therapy within 4 weeks prior to screening visit (except for local treatment for Kaposi's sarcoma) or plan to have such treatment during the study.
- Have taken drugs that affect the immune system, such as systemic corticosteroids, interleukins, vaccines, or interferons, within 4 weeks prior to the screening visit.
- Have had an HIV vaccine within 3 months of the screening visit.
- Have taken recombinant Human Growth Hormone (r-hGH), megestrol acetate, medicines containing oxandrolone, oxymetholone, nandrolone, DHEA, or other testosterone derivatives, or glucocorticoids or other systemic steroids (except inhaled and topical steroids) in the last 4 months or plan to take these drugs during the study.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Summa Health System
Akron, Ohio, 44304
Central Texas Clinical Research
Austin, Texas, 78705
Infectious Diseases Assoc of Brooklyn
Brooklyn, New York, 11215
Long Island College Hospital
Brooklyn, New York, 11217
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, 275997030
Northstar Med Clinic
Chicago, Illinois, 60657
Case Western Reserve Univ
Cleveland, Ohio, 44106
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, 33311
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Gathe, Joseph, M.D.
Houston, Texas, 77004
Diversified Med Practices, PA
Houston, Texas, 77027
Univ of Texas / Med School at Houston
Houston, Texas, 77030
Duval County Health Department
Jacksonville, Florida, 32206
THE Clinic
Los Angeles, California, 90008
Tower Infectious Disease Med Ctr
Los Angeles, California, 90048
Mt Vernon Hospital
Mount Vernon, New York, 10550
Jersey Shore Med Ctr
Neptune City, New Jersey, 07753
Dr Lawrence Fontana
New York, New York, 10003
Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
New York, New York, 10003
Howard Grossman
New York, New York, 10011
Boriken Neighborhood Health Center
New York, New York, 10035
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15221
St Lukes Medical Group
San Diego, California, 92101
UCSD Treatment Ctr
San Diego, California, 921036329
Swedish Med Ctr
Seattle, Washington, 98122
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
Bronx Veterans Affairs Med Ctr
The Bronx, New York, 10468
Infectious Disease Specialists of NJ
Union, New Jersey, 07083
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
About this study
Official title: Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)
The purpose of this study is to see if the findings of increased lactic acid and abnormal fat distribution get better when d4T is replaced with abacavir, abacavir plus lamivudine, or Combivir (a pill containing lamivudine plus zidovudine) in HIV-positive patients taking anti-HIV therapy including stavudine (d4T).
Read the detailed description
Patients are allocated as follows: a) zidovudine-naive patients switch Combivir for d4t and b) zidovudine-experienced or -intolerant patients switch abacavir for d4t. Providers may choose between Combivir or abacavir as a switch for d4t when screening lactate levels are 2.2 mmol/L or more. Additionally, providers may choose to switch a maximum of 2 drugs, one of which must be d4t, in the regimen. Each patient receives 48 weeks of therapy. Visits are made at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Tests, including biopsies, are performed to measure changes in body fat distribution and changes in lactate levels. Virologic and immunologic outcomes, changes in physical signs of lipodystrophy, changes in self-reports of health-related quality-of-life survey and the Body Image Questionnaire, changes in lipid profile and other markers of metabolism, and safety parameters are evaluated also.
- Conditions
- HIV Infections, Lipodystrophy
- Being tested
- Lamivudine/Zidovudine, Abacavir sulfate, Lamivudine
- Keywords
- HIV-1, Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, Lamivudine, Blood, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Lipodystrophy, Combivir, Lactic Acid, 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
LamivudineDrug
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 startMay 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 4
- Primary purpose
- Treatment
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005764
- Sponsor's protocol ID
- 238T
- Other IDs
- ESS40010
- Status last verified
- Jun 2001
- First submitted
- 30 May 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
- Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)
- ClinicalTrials.gov ID
- NCT00005764
- Acronym / sponsor ID
- 238T
- Conditions
- HIV Infections, Lipodystrophy
- Keywords
- HIV-1, Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, Lamivudine, Blood
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- Study start
- May 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 see if the findings of increased lactic acid and abnormal fat distribution get better when d4T is replaced with abacavir, abacavir plus lamivudine, or Combivir (a pill containing lamivudine plus zidovudine) in HIV-positive patients taking anti-HIV therapy including stavudine (d4T).
Detailed description
Patients are allocated as follows: a) zidovudine-naive patients switch Combivir for d4t and b) zidovudine-experienced or -intolerant patients switch abacavir for d4t. Providers may choose between Combivir or abacavir as a switch for d4t when screening lactate levels are 2.2 mmol/L or more. Additionally, providers may choose to switch a maximum of 2 drugs, one of which must be d4t, in the regimen. Each patient receives 48 weeks of therapy. Visits are made at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Tests, including biopsies, are performed to measure changes in body fat distribution and changes in lactate levels. Virologic and immunologic outcomes, changes in physical signs of lipodystrophy, changes in self-reports of health-related quality-of-life survey and the Body Image Questionnaire, changes in lipid profile and other markers of metabolism, and safety parameters are evaluated also.
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 (12 listed)
- Are HIV-positive.
- Are at least 18 years old.
- Agree not to have intercourse 2 weeks before, during, and 2 weeks after study or agree to use effective methods of birth control.
- Have had HIV-1 RNA levels less than 400 copies/ml on the 2 most recent measurements.
- Have at least 1 of the following situations:
Key exclusion criteria (14 listed)
- Have diabetes or kidney failure.
- Have any condition that makes them unable to participate in this study.
- Are unable to take medications by mouth.
- Have serious medical conditions, such as congestive heart failure or other heart disease, which would affect the safety of the patient.
- Are taking or have taken abacavir plus Retrovir or Combivir.
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 | – |
| Lamivudine | 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.
31 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 Lamivudine in people with HIV Infections and Lipodystrophy, run by Glaxo Wellcome at 31 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 12 inclusion and 14 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 31 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.