A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
![](https://webarchive.library.unt.edu/web/20130317082039im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Indinavir sulfate Drug: Lamivudine/Zidovudine Drug: Ritonavir Drug: Amprenavir Drug: Efavirenz Drug: Saquinavir Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Didanosine |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
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 |
Estimated Enrollment: | 300 |
Study Completion Date: | February 2002 |
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.]
![](https://webarchive.library.unt.edu/web/20130317082039im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
![](https://webarchive.library.unt.edu/web/20130317082039im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20130317082039im_/http://clinicaltrials.gov/ct2/html/images/frame/plus.gif)
Study Chair: | John Mellors; William Powderly | |
Study Chair: | Scott Hammer |
![](https://webarchive.library.unt.edu/web/20130317082039im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000918 History of Changes |
Other Study ID Numbers: | ACTG 400, 11356, Substudy A5013s, Substudy A5022s |
Study First Received: | November 2, 1999 |
Last Updated: | May 17, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination HIV Protease Inhibitors Reverse Transcriptase Inhibitors |
Salvage Therapy Anti-HIV Agents Viral Load |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Didanosine Zidovudine Stavudine Lamivudine |
Reverse Transcriptase Inhibitors Efavirenz Lamivudine, zidovudine drug combination Indinavir Saquinavir Ritonavir Nelfinavir Amprenavir Anti-HIV Agents HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on March 14, 2013