Clinical trial NCT00002423: A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir
Official title: A Phase II, Open-Label Trial for Treatment of HIV Infection in Subjects Who Have Failed Initial Combination Therapy With Regimens Containing Indinavir or Nelfinavir: Combination Therapy With 3TC (150 Mg BID), Abacavir (300 Mg BID) and Amprenavir (1200 Mg BID) Plus Either Nelfinavir (1250 Mg BID) or Indinavir (800 Mg TID) for 48 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
HIV Protease Inhibitors
Lamivudine
Indinavir
Nelfinavir
VX 478
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
abacavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and effectiveness of two anti-HIV drug combinations in fighting HIV infection in patients whose viral loads (levels of HIV in the blood) rose with other anti-HIV drug treatments.

Detailed description: Patients experiencing virologic failure while receiving an IDV-containing antiretroviral regimen will receive the 3TC/ABC/APV/NFV combination. Patients experiencing virologic failure while receiving an NFV-containing antiretroviral regimen will receive the 3TC/ABC/APV/IDV combination.

Eligibility criteria: Inclusion Criteria

You may be eligible for this trial if you:

* Are HIV-positive.
* Are 13 years of age or older.
* Are currently taking anti-HIV drugs, 1 of which must be NFV or IDV, and have taken these same drugs for at least 12 weeks.
* In the last 16 weeks your viral load (level of HIV in the blood) dropped below 400 copies/ml and has since increased to at least 1,000 copies/ml, even though you continue to take your anti-HIV drugs.
* Have the written consent of a parent or legal guardian if you are under age 18.
* Agree to practice abstinence or use effective barrier methods of birth control (unless you are physically incapable of becoming pregnant).
* Are willing to complete the 48-week study.

Exclusion Criteria

You will not be eligible for this trial if you:

* Have ever taken the following anti-HIV drugs: ABC, APV, efavirenz (EFV), delavirdine (DLV), nevirapine (NVP), or loviride.
* Have certain AIDS-related infections or diseases, have other serious medical conditions such as diabetes and certain types of heart trouble, or have a history of lymphoma.
* Have had certain types of hepatitis in the past 6 months.
* Have received an HIV vaccine in the past 3 months or a flu vaccine in the past 30 days.
* Have certain digestion problems that make it difficult to take anti-HIV drugs by mouth.
* Have received certain other drugs or treatments in the past 30 days, or will need certain drugs or treatments during the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Saint Francis Mem Hosp
state: California
city: Washington
country: United States
facility: Georgetown Univ Med Ctr
state: District of Columbia
city: Altamonte Springs
country: United States
facility: IDC Research Initiative
state: Florida
city: Bethesda
country: United States
facility: Natl Institute of Allergy and Infectious Diseases
state: Maryland
city: Kansas City
country: United States
facility: Kansas City AIDS Research Consortium
state: Missouri
city: New York
country: United States
facility: Bentley-Salick Med Practice
state: New York
city: Tulsa
country: United States
facility: Associates in Med and Mental Health
state: Oklahoma
city: Portland
country: United States
facility: Portland Veterans Adm Med Ctr / Rsch & Education Grp
state: Oregon
Study officials:
References: