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NCT00000918 Clinical Trial

A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure

HIV Infections Clinical Trial

Official title:
A Phase II, Randomized, Open-Label Comparative Trial of Salvage Antiretroviral Therapies for HIV-Infected Individuals With Virological Evidence of Nelfinavir Treatment Failure as Reflected by Plasma HIV RNA Concentration of >= 1,000 Copies/ml

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000918
Other study ID # ACTG 400
Secondary ID 11356Substudy A5
Status Completed
Phase Phase 2
First received November 2, 1999
Last updated May 17, 2012
Est. completion date February 2002

Study information
Verified date May 2012
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and effectiveness of combining several anti-HIV drugs in order to decrease plasma viral load (level of HIV in the blood) in HIV-positive patients who have failed nelfinavir (NFV) treatment.

In order to determine the ability of a drug regimen to decrease viral load after drug treatment has failed, it is best to test a variety different of drug "cocktails" (drug regimens). The drug cocktails in this study include 2 new nucleoside reverse transcriptase inhibitors (NRTIs), efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor), and either 1 or 2 protease inhibitors. It is important to include multiple drugs from different groups in a drug cocktail since combinations containing fewer drugs are likely to fail.

Description:

To maximize the likelihood of a favorable response to salvage therapy, 4 or 5 drug regimens should be studied. Regimens containing fewer drugs, particularly those lacking a non-nucleoside reverse transcriptase inhibitor (NNRTI) such as efavirenz, are likely to result in an unacceptable rate of virological failure. Therefore, this study examines drug combinations which include two new nucleoside reverse transcriptase inhibitors (NRTIs), the NNRTI efavirenz, and either one or two protease inhibitors which are known not to produce cross-resistance to nelfinavir.

Patients are randomly selected to receive 1 of the following 4 treatment regimens:

Arm A: Ritonavir, saquinavir, efavirenz, and 2 new NRTIs. Arm B: Indinavir, efavirenz and 2 new NRTIs. Arm C: Amprenavir, efavirenz, and 2 new NRTIs. [AS PER AMENDMENT 3/22/00: Patients have the option to increase the APV dose or to add low-dose ritonavir. APV will continue to be provided by the study; ritonavir will not be provided by the study.] Arm D: Indinavir, amprenavir, efavirenz, and 2 new NRTIs. [AS PER AMENDMENT 6/28/99: All treatment regimens must include at least 1 new NRTI.] [AS PER AMENDMENT 3/22/00: ACTG 400 will continue to provide originally randomized study medications to all patients until approximately May 10, 2000, regardless of virologic response. Patients may also add antiretrovirals of their choice to this regimen (not provided by the study).] Clinical assessments are taken at Weeks 2, 4, 8, 12, 16, and every 8 weeks thereafter for the duration of the study. In addition, 2 substudies are being conducted: a drug-interaction substudy and a drug-exposure substudy. [AS PER AMENDMENT 3/22/00: Both substudies are closed to accrual and their pharmacokinetics assessments are discontinued.]

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date February 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria

Patients may be eligible for this study if they:

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

- Are HIV-positive.

- Currently have virologic failure (more than 1,000 copies of HIV RNA per ml).

- Agree to abstinence or use of effective birth control during the study.

- Have been taking NFV for the past 12 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

- Have a fever for 7 days or diarrhea for 30 days before study entry.

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

- Have hepatitis.

- Have any malignancy (cancer) other than minimal Kaposi's sarcoma.

- Are pregnant or breast-feeding.

- Are receiving radiation, chemotherapy, or any therapy for any illness within 14 days of study entry.

- Have taken amprenavir, saquinavir, indinavir or ritonavir for more than 7 days.

- Have received an HIV vaccine 30 days before study entry.

- Are receiving certain other medications.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Indinavir sulfate

• Lamivudine/Zidovudine

• Ritonavir

• Amprenavir

• Efavirenz

• Saquinavir

• Lamivudine

• Stavudine

• Zidovudine

• Didanosine

Locations
Country Name City State
Puerto Rico Univ of Puerto Rico San Juan
United States Emory Univ Atlanta Georgia
United States Univ of Alabama at Birmingham Birmingham Alabama
United States Beth Israel Deaconess - West Campus Boston Massachusetts
United States Harvard (Massachusetts Gen Hosp) Boston Massachusetts
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Univ of North Carolina Chapel Hill North Carolina
United States Cook County Hosp Chicago Illinois
United States Northwestern Univ Med School Chicago Illinois
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Univ of Cincinnati Cincinnati Ohio
United States Case Western Reserve Univ Cleveland Ohio
United States Ohio State Univ Hosp Clinic Columbus Ohio
United States Univ of Colorado Health Sciences Ctr Denver Colorado
United States Duke Univ Med Ctr Durham North Carolina
United States Division of Inf Diseases/ Indiana Univ Hosp Indianapolis Indiana
United States Indiana Univ Hosp Indianapolis Indiana
United States Methodist Hosp of Indiana / Life Care Clinic Indianapolis Indiana
United States UCLA CARE Ctr Los Angeles California
United States Univ of Southern California / LA County USC Med Ctr Los Angeles California
United States Willow Clinic Menlo Park California
United States Univ of Miami School of Medicine Miami Florida
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Beth Israel Med Ctr New York New York
United States Chelsea Ctr New York New York
United States Cornell Univ Med Ctr New York New York
United States Mount Sinai Med Ctr New York New York
United States Univ of Pennsylvania at Philadelphia Philadelphia Pennsylvania
United States Univ of Rochester Medical Center Rochester New York
United States San Francisco AIDS Clinic / San Francisco Gen Hosp San Francisco California
United States San Francisco Gen Hosp San Francisco California
United States Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium San Jose California
United States Marin County Specialty Clinic San Rafael California
United States Univ of Washington Seattle Washington
United States St Louis Regional Hosp / St Louis Regional Med Ctr St Louis Missouri
United States San Mateo AIDS Program / Stanford Univ Stanford California
United States Stanford Univ Med Ctr Stanford California
United States Howard Univ Washington District of Columbia
United States Julio Arroyo West Columbia South Carolina

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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