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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000885 |
Group A:
To compare the time to confirmed virologic failure (2 consecutive plasma HIV-RNA concentrations of 500 copies/ml or more) between the treatment arms: abacavir (ABC) or placebo in combination with zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV). To evaluate the safety and tolerability of these treatment arms. [AS PER AMENDMENT 06/16/99: To compare the time to confirmed treatment failure, permanent discontinuation of treatment, or death between the treatment arms.] [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable.]
Group B:
To compare the proportion of patients who achieve plasma HIV-1 RNA concentrations below 500 copies/ml, as assessed by the standard Roche Amplicor assay at Week 16, or to compare the absolute changes in plasma HIV-1 RNA concentrations at Week 16 across the treatment arms: ABC or approved nucleoside analogs and nelfinavir (NFV) or placebo in combination with efavirenz (EFV) and adefovir dipivoxil. To compare the safety and tolerability of these treatment arms.
Group C:
To monitor plasma HIV-1 RNA trajectory over time and determine the time to a confirmed plasma HIV-1 RNA concentration above 2,000 copies/ml on 2 consecutive determinations for patients treated with ZDV or stavudine (d4T) plus 3TC and IDV.
Group D:
To evaluate plasma HIV-1 RNA responses at Weeks 16 and 48. To evaluate the safety and tolerability of the treatment arms: ABC, EFV, adefovir dipivoxil, and NFV.
This study explores new treatment options for ACTG 320 enrollees (and, if needed, a limited number of non-ACTG 320 volunteers) who have been receiving ZDV (or d4T) plus 3TC and IDV and are currently exhibiting a range of virologic responses. By dividing the study into the corresponding, nonsequential cohorts (Groups A, B, C, D), different approaches to evaluating virologic success, i.e., undetectable plasma HIV-1 RNA levels, and virologic failure, i.e., plasma HIV-1 RNA levels of 500 copies/ml or more [AS PER AMENDMENT 12/27/01: 200 copies/ml or more], are explored while maintaining long-term follow-up of ACTG 320 patients. [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable. This study will examine the question of whether intensification of therapy can prolong the virologic benefit in individuals whose plasma HIV-1 RNA concentrations have been below the limits of assay detection on ZDV (or d4T) plus 3TC plus IDV.]
Condition | Intervention | Phase |
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HIV Infections |
Drug: Indinavir sulfate Drug: Abacavir sulfate Drug: Nelfinavir mesylate Drug: Efavirenz Drug: Levocarnitine Drug: Adefovir dipivoxil Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Didanosine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | A Phase II Study of the Prolongation of Virologic Success (ACTG 372A) and Options for Virologic Failure (ACTG B/C/D) in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320 |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Recommended as an alternative agent for chemoprophylaxis against Mycobacterium avium complex for patients randomized to EFV in Group B or D:
Patients must have:
Non-ACTG patients:
Prior Medication:
Required:
Non-ACTG 320 patients:
ACTG patients:
Group D:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
Concurrent Medication:
Excluded:
To be avoided:
Prior Medication:
Excluded:
Non-ACTG patients:
Caution should be taken in the consumption of alcoholic beverages with study medications.
Study Chair: | Scott Hammer |
Study ID Numbers: | ACTG 372, ACTG 701, ACTG 702, ACTG 706 |
Study First Received: | November 2, 1999 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00000885 |
Health Authority: | United States: Federal Government |
HIV-1 Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine Indinavir |
RNA, Viral Treatment Failure Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Efavirenz Sexually Transmitted Diseases, Viral Stavudine Indinavir Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Immunologic Deficiency Syndromes Virus Diseases |
Didanosine HIV Infections Sexually Transmitted Diseases Adefovir dipivoxil Nelfinavir Abacavir Adefovir Retroviridae Infections Carnitine |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Vitamin B Complex Immune System Diseases Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Vitamins Lentivirus Infections Micronutrients Nucleic Acid Synthesis Inhibitors |