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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000918
First received: November 2, 1999
Last updated: May 17, 2012
Last verified: May 2012

November 2, 1999
May 17, 2012
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Complete list of historical versions of study NCT00000918 on ClinicalTrials.gov Archive Site
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A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure
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

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.

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.]

Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Lamivudine/Zidovudine
  • Drug: Ritonavir
  • Drug: Amprenavir
  • Drug: Efavirenz
  • Drug: Saquinavir
  • Drug: Lamivudine
  • Drug: Stavudine
  • Drug: Zidovudine
  • Drug: Didanosine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
February 2002
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00000918
ACTG 400, 11356, Substudy A5013s, Substudy A5022s
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: John Mellors; William Powderly
Study Chair: Scott Hammer
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP