HIVPhase 4NCT00335270
A Randomized, Prospective Study of the Efficacy, Safety and Tolerability of Two Doses of GW433908Ritonavir Given With Abacavir/Lamivudine Fixed Dose Combination
A Phase 4 study testing fos-amprenavir calcium, ritonavir and abacavir/lamivudine as Epzicom in people with HIV, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the antiretroviral efficacy, safety, and tolerability of fos-amprenavir boosted with either of two doses of ritonavir (RTV) when administered in combination with ABC/3TC (abacavir/lamivudine, Epzicom®) FDC (fixed dose combination) in a once-daily regimen over 96 weeks in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- fos-amprenavir calcium, ritonavir and abacavir/lamivudine as Epzicom
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2007
- 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
- HIV-1 infection
- Male or Female 18 years of age or older
- Has plasma HIV-1 RNA (viral load) 1,000 or more copies/mL at screening
- Subject is antiretroviral-naïve ( less than 7 days of prior therapy with any agent
- Competency
- Not pregnant and willing to use effective birth control if applicable.
Who cannot join
- Inability to comply due to pre-existing mental, physical, or substance abuse disorder or other reason.
- Has active/acute CDC Clinical Category C event at screening.
- Has history of inflammatory bowel disease, gastrointestinal malignancy, intestinal ischemia, malabsorption or other gastrointestinal dysfunction.
- Females who are pregnant or breastfeeding.
- Has a serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the subject.
- Has ongoing clinically relevant pancreatitis or clinically relevant hepatitis at screening.
Show all 16Show fewer
- Requires treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of study drug administration.
- Has an acute laboratory abnormality at screening that, in the opinion of the investigator, should preclude the subject's participation in the study. Any Grade 4 laboratory result would exclude a subject from study participation.
- Has required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or has an anticipated need for such a treatment within the study period.
- Requires treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, vaccines, or interferons) within 28 days prior to screening or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to screening.
- Has a history of allergy to any of the study drugs or any excipients therein.
- Is enrolled or plans to enroll in one or more investigational drug protocols, which may impact HIV RNA suppression.
- Requiring treatment with pharmacological agents for diabetes, or elevated triglycerides/cholesterol.
- Has an AST or ALT >5 times the upper limit of normal (ULN).
- Has an estimated creatinine clearance <50 mL/min via the Cockcroft-Gault method
- Subject requires treatment with any of the following medications within 28 days prior to study drug administration, or the anticipated need during the study: amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergonovine, ergotamine, flecainide, halofantrine, lidocaine, lovastatin, methylergonovine, midazolam, pimozide, propafenone, quinidine, simvastatin, terfenadine, and triazolam, carbamazepine, dexamethasone, phenobarbital, phenytoin, primidone, rifampin, and St. John's Wort (hypericum perforatum)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami School of Medicine
Miami, Florida, 33136
About this study
The purpose of this study is to evaluate the antiretroviral efficacy, safety, and tolerability of fos-amprenavir boosted with either of two doses of ritonavir (RTV) when administered in combination with ABC/3TC (abacavir/lamivudine, Epzicom®) FDC (fixed dose combination) in a once-daily regimen over 96 weeks in ART-naïve, HIV-infected adults
Read the detailed description
The optimal long-term management of HIV-1 infection necessitates the chronic use of highly effective, well-tolerated antiretroviral (ARV) combination therapy, which ideally can preserve future treatment options. Current preferred standard treatment for HIV consists of a regimen composed of a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs). A recent trend that may contribute to improving rates of treatment response is to use regimens with fewer pills and once daily dosing. This study is designed to assess two PI options that consist of four or five pills taken once daily - these options may also offer advantages in terms of metabolic consequences.
The primary objective of this multi-center, open-label, randomized, two-arm, pilot study is to evaluate the antiretroviral efficacy, safety, and tolerability (adverse events and metabolic profile) of fos-amprenavir (fAPV) boosted with either of two doses of ritonavir (RTV) when administered in combination with ABC/3TC (abacavir/lamivudine, Epzicom®) FDC (fixed dose combination) in a once-daily regimen over 48 weeks in ART-naïve, HIV-infected adults. Approximately 100 subjects will be enrolled from about 10 sites in the United States. Subjects must be >18 years of age, be ART-naïve (<7 days of prior therapy with any licensed or investigational ARV drugs) and have a plasma HIV-1 RNA>1,000 copies/mL. A CD4+ cell count >50 cells/mm3 was initially required for eligibility. Amendment 1 has dropped this as a requirement. Subjects will be stratified at entry according to their screening plasma HIV-1 RNA level (<100,000 copies/mL or >100,000 copies/mL). Eligible subjects will be randomized (1:1) to one of the following two treatment arms for 96 weeks; fAPV 1400 mg/RTV 100 mg QD plus ABC 600 mg/3TC 300 mg FDC QD (Treatment Arm A) or fAPV 1400 mg/RTV 200 mg QD plus ABC 600 mg/3TC 300 mg FDC QD (Treatment Arm B).
- Conditions
- HIV
- Being tested
- fos-amprenavir calcium, ritonavir, abacavir/lamivudine as Epzicom
- Keywords
- HIV Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fos-amprenavir calcium, ritonavirDrug
abacavir/lamivudine as EpzicomDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with plasma HIV 1 RNA <400 copies at week 48
Proportion of subjects who experience drug related discontinuations at Week 48
Secondary outcomes (11)
Proportion of subjects who achieve plasma HIV 1 RNA<400 copies/mL at Weeks 24 and 96
Proportion of subjects who achieve plasma HIV-1 RNA <50 copies/mL at Weeks 24, 48, and 96.
Absolute values and change from baseline in plasma HIV-1 RNA and CD4+ cell counts at Weeks 24, 48, and 96.
Development and identification of genotypic resistance mutations and phenotypic resistance at virologic failure.
Incidence of Grades 2 to 4 AEs, treatment-limiting AEs, and serious adverse events (SAEs) over 24, 48, and 96 weeks.
Change from baseline in fat distribution as determined by percent change in body fat using whole body DEXA scans at Weeks 48, 72, and 96.
Change from baseline in subject's self-report of body fat distribution using the Body Image Questionnaire and the investigator's assessment of subject's body fat distribution using FRAM 2 PE (Grunfeld et al., 2003) at Weeks 48, 72, and 96.
Change from baseline in fasting lipids (total cholesterol, HDL cholesterol, direct LDL cholesterol, and triglycerides), fasting glucose and insulin measurements at Weeks 12, 24, 48, and 96.
Measurements of plasma APV trough concentrations at Weeks 4, 8, 24, and 48
To assess relationships between plasma APV trough concentrations and outcomes, including safety, efficacy and the development of resistance.
Adherence to each treatment regimen using pill counts of unused study drugs and subject self-assessment adherence questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Charles Hicks, MD, Principal investigator, Duke UniversityRafael E Campo, MD, Principal investigator, University of MiamiJason Flamm, MD, Principal investigator, Medicine 4Jeffrey Lennox, MD, Principal investigator, Emory UniversityRodger MacArthur, MD, Principal investigator, Wayne State UniversityJeffrey P Nadler, MD, Principal investigator, Hillsborough County Health DepartmentJohn H. Schrank, MD, Principal investigator, Greenville Hospital SystemLouis Sloan, MD, Principal investigator, North Texas Infectious Disease Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335270
- Sponsor's protocol ID
- 6692-05-12R1
- Status last verified
- May 2013
- First submitted
- 7 Jun 2006
- Last updated
- 14 May 2013
- Results posted
- No
Publications
Behrens G, Dejam A, Schmidt H, Balks HJ, Brabant G, Korner T, Stoll M, Schmidt RE. Impaired glucose tolerance, beta cell function and lipid metabolism in HIV patients under treatment with protease inhibitors. AIDS. 1999 Jul 9;13(10):F63-70. doi: 10.1097/00002030-199907090-00001.
PubMed 10416516Carpenter CC, Cooper DA, Fischl MA, Gatell JM, Gazzard BG, Hammer SM, Hirsch MS, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Saag MS, Schechter M, Schooley RT, Thompson MA, Vella S, Yeni PG, Volberding PA. Antiretroviral therapy in adults: updated recommendations of the International AIDS Society-USA Panel. JAMA. 2000 Jan 19;283(3):381-90. doi: 10.1001/jama.283.3.381.
PubMed 10647802Dube MP, Sprecher D, Henry WK, Aberg JA, Torriani FJ, Hodis HN, Schouten J, Levin J, Myers G, Zackin R, Nevin T, Currier JS; Adult AIDS Clinical Trial Group Cardiovascular Disease Focus Group. Preliminary guidelines for the evaluation and management of dyslipidemia in adults infected with human immunodeficiency virus and receiving antiretroviral therapy: Recommendations of the Adult AIDS Clinical Trial Group Cardiovascular Disease Focus Group. Clin Infect Dis. 2000 Nov;31(5):1216-24. doi: 10.1086/317429. Epub 2000 Nov 7.
PubMed 11073755Fung HB, Kirschenbaum HL, Hameed R. Amprenavir: a new human immunodeficiency virus type 1 protease inhibitor. Clin Ther. 2000 May;22(5):549-72. doi: 10.1016/S0149-2918(00)80044-2.
PubMed 10868554McComsey GA, Ward DJ, Hessenthaler SM, Sension MG, Shalit P, Lonergan JT, Fisher RL, Williams VC, Hernandez JE; Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL; ESS40010) Study Team. Improvement in lipoatrophy associated with highly active antiretroviral therapy in human immunodeficiency virus-infected patients switched from stavudine to abacavir or zidovudine: the results of the TARHEEL study. Clin Infect Dis. 2004 Jan 15;38(2):263-70. doi: 10.1086/380790. Epub 2003 Dec 18.
PubMed 14699460Moore KH, Barrett JE, Shaw S, Pakes GE, Churchus R, Kapoor A, Lloyd J, Barry MG, Back D. The pharmacokinetics of lamivudine phosphorylation in peripheral blood mononuclear cells from patients infected with HIV-1. AIDS. 1999 Nov 12;13(16):2239-50. doi: 10.1097/00002030-199911120-00006.
PubMed 10563709Noble S, Goa KL. Amprenavir: a review of its clinical potential in patients with HIV infection. Drugs. 2000 Dec;60(6):1383-410. doi: 10.2165/00003495-200060060-00012.
PubMed 11152018Rodriguez-French A, Boghossian J, Gray GE, Nadler JP, Quinones AR, Sepulveda GE, Millard JM, Wannamaker PG. The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients. J Acquir Immune Defic Syndr. 2004 Jan 1;35(1):22-32. doi: 10.1097/00126334-200401010-00003.
PubMed 14707788Tsiodras S, Mantzoros C, Hammer S, Samore M. Effects of protease inhibitors on hyperglycemia, hyperlipidemia, and lipodystrophy: a 5-year cohort study. Arch Intern Med. 2000 Jul 10;160(13):2050-6. doi: 10.1001/archinte.160.13.2050.
PubMed 10888979Walli R, Herfort O, Michl GM, Demant T, Jager H, Dieterle C, Bogner JR, Landgraf R, Goebel FD. Treatment with protease inhibitors associated with peripheral insulin resistance and impaired oral glucose tolerance in HIV-1-infected patients. AIDS. 1998 Oct 22;12(15):F167-73. doi: 10.1097/00002030-199815000-00001.
PubMed 9814858
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Study of the Efficacy, Safety and Tolerability of Two Doses of GW433908Ritonavir Given With Abacavir/Lamivudine Fixed Dose Combination
- ClinicalTrials.gov ID
- NCT00335270
- Acronym / sponsor ID
- 6692-05-12R1
- Conditions
- HIV
- Keywords
- HIV Type 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007
- First posted
- 9 Jun 2006 (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 evaluate the antiretroviral efficacy, safety, and tolerability of fos-amprenavir boosted with either of two doses of ritonavir (RTV) when administered in combination with ABC/3TC (abacavir/lamivudine, Epzicom®) FDC (fixed dose combination) in a once-daily regimen over 96 weeks in ART-naïve, HIV-infected adults
Detailed description
The optimal long-term management of HIV-1 infection necessitates the chronic use of highly effective, well-tolerated antiretroviral (ARV) combination therapy, which ideally can preserve future treatment options. Current preferred standard treatment for HIV consists of a regimen composed of a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs). A recent trend that may contribute to improving rates of treatment response is to use regimens with fewer pills and once daily dosing. This study is designed to assess two PI options that consist of four or five pills taken once daily - these options may also offer advantages in terms of metabolic consequences.
The primary objective of this multi-center, open-label, randomized, two-arm, pilot study is to evaluate the antiretroviral efficacy, safety, and tolerability (adverse events and metabolic profile) of fos-amprenavir (fAPV) boosted with either of two doses of ritonavir (RTV) when administered in combination with ABC/3TC (abacavir/lamivudine, Epzicom®) FDC (fixed dose combination) in a once-daily regimen over 48 weeks in ART-naïve, HIV-infected adults. Approximately 100 subjects will be enrolled from about 10 sites in the United States. Subjects must be >18 years of age, be ART-naïve (<7 days of prior therapy with any licensed or investigational ARV drugs) and have a plasma HIV-1 RNA>1,000 copies/mL. A CD4+ cell count >50 cells/mm3 was initially required for eligibility. Amendment 1 has dropped this as a requirement. Subjects will be stratified at entry according to their screening plasma HIV-1 RNA level (<100,000 copies/mL or >100,000 copies/mL). Eligible subjects will be randomized (1:1) to one of the following two treatment arms for 96 weeks; fAPV 1400 mg/RTV 100 mg QD plus ABC 600 mg/3TC 300 mg FDC QD (Treatment Arm A) or fAPV 1400 mg/RTV 200 mg QD plus ABC 600 mg/3TC 300 mg FDC QD (Treatment Arm B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-1 infection
- Male or Female 18 years of age or older
- Has plasma HIV-1 RNA (viral load) 1,000 or more copies/mL at screening
- Subject is antiretroviral-naïve ( less than 7 days of prior therapy with any agent
- Competency
Key exclusion criteria (16 listed)
- Inability to comply due to pre-existing mental, physical, or substance abuse disorder or other reason.
- Has active/acute CDC Clinical Category C event at screening.
- Has history of inflammatory bowel disease, gastrointestinal malignancy, intestinal ischemia, malabsorption or other gastrointestinal dysfunction.
- Females who are pregnant or breastfeeding.
- Has a serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the subject.
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 |
|---|---|---|
| fos-amprenavir calcium, ritonavir | Drug | – |
| abacavir/lamivudine as Epzicom | Drug | – |
Primary outcome
Proportion of subjects with plasma HIV 1 RNA <400 copies at week 48
Proportion of subjects who experience drug related discontinuations at Week 48
11 secondary outcomes
Proportion of subjects who achieve plasma HIV 1 RNA<400 copies/mL at Weeks 24 and 96
Proportion of subjects who achieve plasma HIV-1 RNA <50 copies/mL at Weeks 24, 48, and 96.
Absolute values and change from baseline in plasma HIV-1 RNA and CD4+ cell counts at Weeks 24, 48, and 96.
Development and identification of genotypic resistance mutations and phenotypic resistance at virologic failure.
Incidence of Grades 2 to 4 AEs, treatment-limiting AEs, and serious adverse events (SAEs) over 24, 48, and 96 weeks.
Change from baseline in fat distribution as determined by percent change in body fat using whole body DEXA scans at Weeks 48, 72, and 96.
Change from baseline in subject's self-report of body fat distribution using the Body Image Questionnaire and the investigator's assessment of subject's body fat distribution using FRAM 2 PE (Grunfeld et al., 2003) at Weeks 48, 72, and 96.
Change from baseline in fasting lipids (total cholesterol, HDL cholesterol, direct LDL cholesterol, and triglycerides), fasting glucose and insulin measurements at Weeks 12, 24, 48, and 96.
Measurements of plasma APV trough concentrations at Weeks 4, 8, 24, and 48
To assess relationships between plasma APV trough concentrations and outcomes, including safety, efficacy and the development of resistance.
Adherence to each treatment regimen using pill counts of unused study drugs and subject self-assessment adherence questionnaire.
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 14 May 2013.
- Background: PubMed 10416516Behrens G, Dejam A, Schmidt H, Balks HJ, Brabant G, Korner T, Stoll M, Schmidt RE. Impaired glucose tolerance, beta cell function and lipid metabolism in HIV patients under treatment with protease inhibitors. AIDS. 1999 Jul 9;13(10):F63-70. doi: 10.1097/00002030-199907090-00001.
- Background: PubMed 10647802Carpenter CC, Cooper DA, Fischl MA, Gatell JM, Gazzard BG, Hammer SM, Hirsch MS, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Saag MS, Schechter M, Schooley RT, Thompson MA, Vella S, Yeni PG, Volberding PA. Antiretroviral therapy in adults: updated recommendations of the International AIDS Society-USA Panel. JAMA. 2000 Jan 19;283(3):381-90. doi: 10.1001/jama.283.3.381.
- Background: PubMed 11073755Dube MP, Sprecher D, Henry WK, Aberg JA, Torriani FJ, Hodis HN, Schouten J, Levin J, Myers G, Zackin R, Nevin T, Currier JS; Adult AIDS Clinical Trial Group Cardiovascular Disease Focus Group. Preliminary guidelines for the evaluation and management of dyslipidemia in adults infected with human immunodeficiency virus and receiving antiretroviral therapy: Recommendations of the Adult AIDS Clinical Trial Group Cardiovascular Disease Focus Group. Clin Infect Dis. 2000 Nov;31(5):1216-24. doi: 10.1086/317429. Epub 2000 Nov 7.
- Background: PubMed 10868554Fung HB, Kirschenbaum HL, Hameed R. Amprenavir: a new human immunodeficiency virus type 1 protease inhibitor. Clin Ther. 2000 May;22(5):549-72. doi: 10.1016/S0149-2918(00)80044-2.
- Background: PubMed 14699460McComsey GA, Ward DJ, Hessenthaler SM, Sension MG, Shalit P, Lonergan JT, Fisher RL, Williams VC, Hernandez JE; Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL; ESS40010) Study Team. Improvement in lipoatrophy associated with highly active antiretroviral therapy in human immunodeficiency virus-infected patients switched from stavudine to abacavir or zidovudine: the results of the TARHEEL study. Clin Infect Dis. 2004 Jan 15;38(2):263-70. doi: 10.1086/380790. Epub 2003 Dec 18.
- Background: PubMed 10563709Moore KH, Barrett JE, Shaw S, Pakes GE, Churchus R, Kapoor A, Lloyd J, Barry MG, Back D. The pharmacokinetics of lamivudine phosphorylation in peripheral blood mononuclear cells from patients infected with HIV-1. AIDS. 1999 Nov 12;13(16):2239-50. doi: 10.1097/00002030-199911120-00006.
- Background: PubMed 11152018Noble S, Goa KL. Amprenavir: a review of its clinical potential in patients with HIV infection. Drugs. 2000 Dec;60(6):1383-410. doi: 10.2165/00003495-200060060-00012.
- Background: PubMed 14707788Rodriguez-French A, Boghossian J, Gray GE, Nadler JP, Quinones AR, Sepulveda GE, Millard JM, Wannamaker PG. The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients. J Acquir Immune Defic Syndr. 2004 Jan 1;35(1):22-32. doi: 10.1097/00126334-200401010-00003.
- Background: PubMed 10888979Tsiodras S, Mantzoros C, Hammer S, Samore M. Effects of protease inhibitors on hyperglycemia, hyperlipidemia, and lipodystrophy: a 5-year cohort study. Arch Intern Med. 2000 Jul 10;160(13):2050-6. doi: 10.1001/archinte.160.13.2050.
- Background: PubMed 9814858Walli R, Herfort O, Michl GM, Demant T, Jager H, Dieterle C, Bogner JR, Landgraf R, Goebel FD. Treatment with protease inhibitors associated with peripheral insulin resistance and impaired oral glucose tolerance in HIV-1-infected patients. AIDS. 1998 Oct 22;12(15):F167-73. doi: 10.1097/00002030-199815000-00001.
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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.
Charles Hicks, MD principal investigator
Duke University
Rafael E Campo, MD principal investigator
University of Miami
Jason Flamm, MD principal investigator
Medicine 4
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fos-amprenavir calcium, ritonavir and abacavir/lamivudine as Epzicom in people with HIV, run by Duke University at 1 site 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 6 inclusion and 16 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 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Proportion of subjects with plasma HIV 1 RNA <400 copies at week 48. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00335270, which also lists 10 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 14 May 2013.