A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT (SUPPoRT)
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ClinicalTrials.gov Identifier: NCT00727597 |
Recruitment Status :
Completed
First Posted : August 4, 2008
Results First Posted : July 2, 2013
Last Update Posted : July 2, 2013
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Condition or disease | Intervention/treatment | Phase |
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Human Immunodeficiency Virus Infections | Drug: Efavirenz 600mg Drug: Boosted Lexiva | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 101 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | July 2011 |
Arm | Intervention/treatment |
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Experimental: Arm A : Boosted Lexiva plus Epzicom
Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
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Drug: Boosted Lexiva
Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg) The intervention may be switched for the following reasons:
Other Name: Fosamprenavir(Lexiva) |
Experimental: Arm B: Efavirenz plus Epzicom
QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
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Drug: Efavirenz 600mg
QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg) The intervention may be switched for the following reasons:
Other Name: Efavirenz(Sustiva)600 mg |
- Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV) [ Time Frame: 96 weeks ]
Subjects were randomized and initiated treatment on one of the antiretroviral arms(FPV/r or EFV) at study Entry visit. Subjects would be switched for the follwing reasons:
- To resolve a Grade 3 or 4 Adverse Event
- The subject experienced a virologic failure (as defined in section 3.6.2)
- The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue
- The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)
- Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events [ Time Frame: 96 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Screening plasma HIV-1 RNA viral load >5000 copies/mL Self-identification as having any non-White/Caucasian European geographic ancestry (i.e., an individual is eligible if she/he does not have any White/Caucasian European ancestry; OR an individual is eligible if she/he indicates a mix of White/Caucasian European ancestry AND one or more other geographic ancestries); Antiretroviral-naïve (no treatment with any antiretroviral drug in the 28 days prior to study entry and ≤14 days of treatment ever with any antiretroviral drug) Negative test for the HLA-B*5701 allele Ability and willingness to give written informed consent
Either gender is eligible, but enrollment of at least two female subjects to every one male subject is strongly encouraged. A female subject is eligible to participate in the study if she is of:
- Non-childbearing potential or,
- Childbearing potential with a negative pregnancy test at screen and agrees to use one of the following methods of contraception:
i. Agreement for complete abstinence from intercourse from 2 weeks prior to administration of investigational products, throughout the study, and for 2 weeks after discontinuation of all study medications; ii. Double barrier contraception (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); iii. Any intrauterine device (IUD) with published data showing that the expected failure rate is less than 1% per year (not all IUDs meet this criterion); iv. Any other method with published data showing that the lowest expected failure rate for the method is less than 1% per year. v. Sterilization (female subject or male partner of female subject)
Exclusion Criteria:
Screening HIV-1 genotype indicating the presence of any of the following mutations in the reverse transcriptase (RT) region: K65R, L74V, K103N, Y115F, Y181C/I, Y188C/L/H or G190S/A, or a combination of two or more thymidine analog mutations (M41L, D67N, K70R, K219Q or E) that include changes at either L210 or T215, associated with resistance to abacavir, lamivudine, or efavirenz; OR within the protease region, detection of any of the following mutations associated with resistance to fosamprenavir or ritonavir: I50V, I54L/M, I84V, or the combination of the two mutations V32I+I147V Positive for Hepatitis B surface antigen (HBsAg+)
Requirement for active treatment for hepatitis C virus infection, as indicated by both a positive Hepatitis C Virus serology AND either:
- Decompensated liver disease, or
- Aspartate aminotransferase (AST) >3X the upper limit of normal (ULN), or
- Alanine aminotransferase (ALT) >3X the ULN Currently pregnant, intending to become pregnant during the study period, or breast-feeding Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), any vaccinations, systemic cytotoxic chemotherapy, or investigational therapy within 28 days prior to study entry. Chronic treatment with prednisone at a daily dose of 10 mg or less is permitted. Acute treatment (less than 21 days) with larger doses of corticosteroids for acute therapy is permitted.
Active or suspected drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements Judged by the investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results Active or acute Centers for Disease Control Clinical Category C event at screening. (Note: Treatment for the acute event must have been completed at least 28 days prior to screening.) Clinically relevant pancreatitis or clinically relevant hepatitis at screening Hgb<8g/dl, platelet count <50,000/mm3, calculated creatinine clearance <50ml/min via Cockroft-Gault equation, or AST or ALT > 5X the ULN Any Grade 4 laboratory abnormality

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727597
United States, District of Columbia | |
Georgetown University | |
Washington, District of Columbia, United States, 20007 |
Principal Investigator: | Princy Kumar, MD | Georgetown University |
Responsible Party: | Princy Kumar, MD, Principal Investigator, Georgetown University |
ClinicalTrials.gov Identifier: | NCT00727597 |
Other Study ID Numbers: |
COL 110408 |
First Posted: | August 4, 2008 Key Record Dates |
Results First Posted: | July 2, 2013 |
Last Update Posted: | July 2, 2013 |
Last Verified: | June 2013 |
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Virus Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Efavirenz Fosamprenavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents |