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NCT00000912

A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

475 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2000-05-31

Brief Summary

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The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while on the treatment. This study evaluates the safety of these drug combinations, which include an experimental protease inhibitor (PI), amprenavir.

Despite the success that many patients have had with PI treatment regimens, there is still a possibility that patients receiving PIs may continue to have high HIV blood levels. Because of this possibility, alternative drug combinations containing PIs are being studied. It appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in patients with prior PI treatment experience.

Detailed Description

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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. \[AS PER AMENDMENT 3/2/00: Gilead Sciences has terminated its U.S. development of ADV for HIV infection. Gilead will continue to supply ADV for patients in ACTG 398 until the study closes. Patients who are receiving ADV at the completion of the study may continue to access ADV through the Expanded Access Program, provided that the physician and patient have determined that continued use of ADV is beneficial.\]

Conditions

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HIV Infections

Keywords

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Placebos Drug Therapy, Combination HIV Protease Inhibitors VX 478 Anti-HIV Agents Viral Load efavirenz

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Indinavir sulfate

Intervention Type DRUG

Abacavir sulfate

Intervention Type DRUG

Amprenavir

Intervention Type DRUG

Nelfinavir mesylate

Intervention Type DRUG

Efavirenz

Intervention Type DRUG

Levocarnitine

Intervention Type DRUG

Adefovir dipivoxil

Intervention Type DRUG

Saquinavir

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Hammer

Role: STUDY_CHAIR

John Mellors

Role: STUDY_CHAIR

Locations

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Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States

Site Status

USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr

Los Angeles, California, United States

Site Status

UCLA CARE Ctr

Los Angeles, California, United States

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Willow Clinic

Menlo Park, California, United States

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Univ of California / San Diego Treatment Ctr

San Diego, California, United States

Site Status

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, United States

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San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, California, United States

Site Status

San Mateo AIDS Program / Stanford Univ

Stanford, California, United States

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Stanford Univ Med Ctr

Stanford, California, United States

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Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

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Howard Univ

Washington D.C., District of Columbia, United States

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Univ of Miami School of Medicine

Miami, Florida, United States

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Emory Univ

Atlanta, Georgia, United States

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Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr

Atlanta, Georgia, United States

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Queens Med Ctr

Honolulu, Hawaii, United States

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Univ of Hawaii

Honolulu, Hawaii, United States

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Tripler Army Med Ctr

Tripler AMC, Hawaii, United States

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Northwestern Univ Med School

Chicago, Illinois, United States

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Cook County Hosp

Chicago, Illinois, United States

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Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

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Charity Hosp / Tulane Univ Med School

New Orleans, Louisiana, United States

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Tulane Univ School of Medicine

New Orleans, Louisiana, United States

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Johns Hopkins Hosp

Baltimore, Maryland, United States

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Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, United States

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Boston Med Ctr

Boston, Massachusetts, United States

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Univ of Minnesota

Minneapolis, Minnesota, United States

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St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, United States

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