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A Phase II, Randomized Trial of Amprenavir as Part of Dual Protease Inhibitor Regimens (Placebo-Controlled) in Combination With Abacavir, Efavirenz, and Adefovir Dipivoxil Versus Amprenavir Alone in HIV-Infected Subjects With Prior Exposure to Approved Protease Inhibitors and Loss of Virologic Suppression as Reflected by a Plasma HIV-1 RNA Concentration >= 1,000 Copies/ml


Phase 2
13 Years
N/A
Not Enrolling
Both
HIV Infections

Thank you

Trial Information

A Phase II, Randomized Trial of Amprenavir as Part of Dual Protease Inhibitor Regimens (Placebo-Controlled) in Combination With Abacavir, Efavirenz, and Adefovir Dipivoxil Versus Amprenavir Alone in HIV-Infected Subjects With Prior Exposure to Approved Protease Inhibitors and Loss of Virologic Suppression as Reflected by a Plasma HIV-1 RNA Concentration >= 1,000 Copies/ml


A number of studies both within and outside the ACTG have been initiated or are in
development to try to address the issue of alternative treatments for patients who either do
not achieve or lose virologic control while receiving protease inhibitors (PIs). Amprenavir
(APV) is an attractive candidate to investigate as part of salvage regimens because: 1) it
has substantial antiretroviral activity; 2) there are preliminary in vitro and in vivo data
that suggest that resistance to this agent may be mediated in part by a unique mutation
(I50V); and 3) its cross-resistance profile to the approved PIs is uncertain.

Patients are selectively randomized to 1 of 4 study arms based on prior PI experience. Those
randomized to Arms A, B, or C receive 2 PIs, 1 of which is amprenavir (APV), and those
randomized to Arm D receive a single PI (APV) as part of their treatment regimen, as
follows:

Arm A: APV plus saquinavir soft gel capsule (SQVsgc) plus abacavir (ABC) plus efavirenz
(EFV) plus adefovir (ADV).

Arm B: APV plus indinavir (IDV) plus ABC plus EFV plus ADV. Arm C: APV plus nelfinavir (NFV)
plus ABC plus EFV plus ADV. Arm D: APV plus placebo (NFV, IDV, or SQVsgc) plus ABC plus EFV
plus ADV. All patients receive L-carnitine supplementation. All patients receive clinical
physical assessments and laboratory testing during study as follows: Weeks 2, 4, and every 4
weeks thereafter. A primary analysis is performed after the last patient has reached 24
weeks. [AS PER AMENDMENT 3/2/00: At that time, all patients are unblinded to their original
treatment assignment.] Patients who experience virologic failure are unblinded and may
choose 1 of the following 3 options: Continue study medications open-label, permanently
discontinue study medications, or selectively continue study medications [AS PER AMENDMENT
3/2/00: from the arm the patient was originally randomized to] and combine with other
approved antiretroviral agents. [AS PER AMENDMENT 3/2/00: For patients adding didanosine
(ddI) to their regimens, monitoring for the development of pancreatitis is crucial.] Final
evaluations are required for those patients who are off drug during the immediate 8-week
period following the last dose of study treatment. Beyond 8 weeks, they are followed for
incidence of death, cancer, congenital anomalies, and permanent disabilities. [AS PER
AMENDMENT 3/2/00: Gilead Sciences has terminated its U.S. development of ADV for HIV
infection. Gilead will continue to supply ADV for patients in ACTG 398 until the study
closes. Patients who are receiving ADV at the completion of the study may continue to access
ADV through the Expanded Access Program, provided that the physician and patient have
determined that continued use of ADV is beneficial.]

Inclusion Criteria


Inclusion Criteria

Patients may be eligible for this study if they:

- Are HIV-positive.

- Have current virologic failure (2 consecutive HIV blood levels above 1,000 copies/ml)
while on PIs.

- Are over 13 years of age (consent of parent or guardian required if under 18).

- Agree to practice abstinence or use effective methods of birth control during the
study and for 90 days after.

Exclusion Criteria

Patients will not be eligible for this study if they:

- Have hepatitis within 90 days prior to study entry.

- Have a history of a peripheral neuropathy within 60 days of study entry.

- Have an unexplained temperature for a 7-day period.

- Have chronic diarrhea within 30 days prior to study entry.

- Have cancer requiring chemotherapy.

- Received any therapy for infection or other illness within 30 days prior to study
entry.

- Have received certain other medications.

- Are pregnant or breast-feeding.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Principal Investigator

Scott Hammer

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 398

NCT ID:

NCT00000912

Start Date:

Completion Date:

May 2000

Related Keywords:

  • HIV Infections
  • Placebos
  • Drug Therapy, Combination
  • HIV Protease Inhibitors
  • VX 478
  • Anti-HIV Agents
  • Viral Load
  • efavirenz
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

San Francisco Gen HospSan Francisco, California  941102859
Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Univ of Rochester Medical CenterRochester, New York  14642
UCLA CARE CtrLos Angeles, California  90095
Univ of California / San Diego Treatment CtrSan Diego, California  921036325
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
Univ of Colorado Health Sciences CtrDenver, Colorado  80262
Univ of Miami School of MedicineMiami, Florida  331361013
Rush Presbyterian - Saint Luke's Med CtrChicago, Illinois  60612
Northwestern Univ Med SchoolChicago, Illinois  60611
Tulane Univ School of MedicineNew Orleans, Louisiana  70112
Harvard (Massachusetts Gen Hosp)Boston, Massachusetts  02114
Boston Med CtrBoston, Massachusetts  02118
Univ of MinnesotaMinneapolis, Minnesota  55455
SUNY / Erie County Med Ctr at BuffaloBuffalo, New York  14215
Cornell Univ Med CtrNew York, New York  10021
Mount Sinai Med CtrNew York, New York  10029
Duke Univ Med CtrDurham, North Carolina  27710
Ohio State Univ Hosp ClinicColumbus, Ohio  432101228
Milton S Hershey Med CtrHershey, Pennsylvania  170330850
Univ of WashingtonSeattle, Washington  98105
Johns Hopkins HospBaltimore, Maryland  21287
Charity Hosp / Tulane Univ Med SchoolNew Orleans, Louisiana  70112
St Louis Regional Hosp / St Louis Regional Med CtrSt Louis, Missouri  63112
Univ of Southern California / LA County USC Med CtrLos Angeles, California  900331079
Cook County HospChicago, Illinois  60612
Moses H Cone Memorial HospGreensboro, North Carolina  27401
Univ of CincinnatiCincinnati, Ohio  452670405
Univ of Pennsylvania at PhiladelphiaPhiladelphia, Pennsylvania  19104
Santa Clara Valley Med Ctr / AIDS Community Rsch ConsortiumSan Jose, California  951282699
Stanford Univ Med CtrStanford, California  943055107
San Mateo AIDS Program / Stanford UnivStanford, California  943055107
Howard UnivWashington, District of Columbia  20059
Univ of HawaiiHonolulu, Hawaii  96816
Univ of Texas GalvestonGalveston, Texas  775550435
Queens Med CtrHonolulu, Hawaii  96816
Emory UnivAtlanta, Georgia  30308
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo CtrAtlanta, Georgia  303652225
Willow ClinicMenlo Park, California  94025
Univ of Pittsburgh Med CtrPittsburgh, Pennsylvania  15213
Chelsea CtrNew York, New York  10021
USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med CtrLos Angeles, California  900334508
Tripler Army Med CtrTripler AMC, Hawaii  96859