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AzTrials

HIV InfectionsPhase 3NCT00011128

Salvage Treatment, Resistance Testing, and Withdrawal of Anti-HIV Drugs for HIV Patients Failing Current Anti-HIV Treatment

A Phase 3 study testing Antiretroviral Treatment Interruption in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 30 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to test another way to control the amount of HIV in the blood (viral load). Studies show that stopping all anti-HIV drugs for a time before switching to new anti-HIV drugs may improve the response in some individuals who are failing treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Antiretroviral Treatment Interruption
How many people
0 participants
Where
30 sitesin 2 countries
Study dates
Start not givento not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients may be eligible for this study if they:
  • Are HIV-infected.
  • Are likely to have drug-resistant HIV from having taken all types of anti-HIV drugs (protease inhibitors [PIs], nucleoside reverse transcriptase inhibitors [NRTIs], and nonnucleoside reverse transcriptase inhibitors [NNRTIs]), and having failed treatment prior to the current treatment for reasons other than toxicity.
  • Are currently receiving anti-HIV treatment with at least 3 drugs. Low doses of ritonavir (100 to 200 mg twice daily) taken with 1 other PI is counted as a single PI.
  • Are currently failing treatment due to a high viral load (amount of HIV in the blood).
  • Have had a new anti-HIV drug combination selected.
  • Are at least 18 years old.
  • This study has been changed to remove CD4 counts as an inclusion criterion. In the previous version of the protocol, patients were required to have a CD4 count of 150 cells/ml or more within 42 days prior to study entry.

Who cannot join

  • Patients will not be eligible for this study if they:
  • Have stopped treatment for more than 4 weeks in the past 6 months.
  • Are pregnant or breast-feeding.
  • Have cancer that requires systemic treatment or radiation.
  • Have received the following medications affecting the immune system within 14 days before entry: erythropoietin; Granulocyte Colony Stimulating Factor (G-CSF), including Granulocyte Macrophage Colony Stimulating Factors (GM-CSF); interleukins; or therapeutic HIV vaccines.

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States29 sites

  • Univ of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Beth Israel Deaconess - West Campus

    Boston, Massachusetts, 02215

  • SUNY / Erie County Med Ctr at Buffalo

    Buffalo, New York, 14215

  • Rush Presbyterian - Saint Luke's Med Ctr

    Chicago, Illinois, 60612

  • The CORE Ctr

    Chicago, Illinois, 60612

  • Univ of Cincinnati

    Cincinnati, Ohio, 452670405

  • Children's Med Ctr of Dallas

    Dallas, Texas, 75235

  • Univ of Colorado Health Sciences Ctr

    Denver, Colorado, 80262

  • Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • Univ of Hawaii

    Honolulu, Hawaii, 96816

  • Indiana Univ Hosp

    Indianapolis, Indiana, 462025250

  • Methodist Hosp of Indiana / Life Care Clinic

    Indianapolis, Indiana, 46202

  • Wishard Hosp

    Indianapolis, Indiana, 46202

  • UCLA CARE Ctr

    Los Angeles, California, 90095

  • Willow Clinic

    Menlo Park, California, 94025

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

  • Vanderbilt Univ Med Ctr

    Nashville, Tennessee, 37203

  • Beth Israel Med Ctr

    New York, New York, 10003

  • Cornell Clinical Trials Unit - Chelsea Clinic

    New York, New York, 10011

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Cornell Univ Med Ctr

    New York, New York, 10021

  • Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Univ of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Univ of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Community Health Network Inc

    Rochester, New York, 14642

  • Univ of Rochester Medical Center

    Rochester, New York, 14642

  • Univ of California, San Diego

    San Diego, California, 92103

  • San Mateo AIDS Program / Stanford Univ

    Stanford, California, 943055107

  • Stanford Univ Med Ctr

    Stanford, California, 943055107

Other trials in United States

Puerto Rico1 site

  • Univ of Puerto Rico

    San Juan, 009365067

Other trials in Puerto Rico

About this study

Official title: Phase III Evaluation of the Role of Temporary Cessation of Antiretroviral Treatment and Resistance Testing-Based Selection of Antiretroviral Drugs in the Virologic Response to Salvage Therapy for Heavily Treatment-Experienced HIV-Infected Individuals Failing Current Antiretroviral Therapy

The purpose of this study is to test another way to control the amount of HIV in the blood (viral load).

Studies show that stopping all anti-HIV drugs for a time before switching to new anti-HIV drugs may improve the response in some individuals who are failing treatment. Other studies suggest a benefit if drug-resistance tests are used in selecting a new anti-HIV drug treatment. This study tests the effect of stopping anti-HIV drugs for a time before switching to anti-HIV drugs selected using drug-resistance test results.

Read the detailed description

Virologic failure occurs in a large proportion of individuals receiving treatment with combination antiretroviral therapy. Studies suggest that treatment interruption prior to initiation of a multiple-drug rescue regimen may improve virologic response in individuals who have failed several prior antiretroviral regimens. Other studies suggest there is a virologic benefit derived from using genotypic or phenotypic resistance testing in selecting salvage therapy regimens for patients failing antiretroviral therapy. This study tests the hypothesis that salvage regimens selected on the basis of HIV-1 resistance genotype, phenotype [AS PER AMENDMENT 02/19/02: virtual phenotype], and treatment history will be more effective if there is a period of treatment interruption before initiating that regimen.

Patients continue their antiretroviral therapy until randomization. Based on the results of the pre-entry genotype and phenotype [AS PER AMENDMENT 02/19/02: virtual phenotype] tests and treatment history, an individualized salvage therapy regimen (not provided by the study) is selected by the site investigator(s). Additionally, patients start or continue maintenance therapy (not provided by the study) for opportunistic infections (OIs). Patients are randomized to 1 of 2 treatment arms. In Arm A, patients have antiretroviral treatment interruption for a period of 16 weeks (Step 1), followed by initiation of the [AS PER AMENDMENT 02/19/02: best available] salvage therapy regimen (Step 2). [AS PER AMENDMENT 02/19/02: Patients in Arm A will be placed immediately on their individualized salvage regimen before the end of the 16-week period of treatment interruption if their CD4 count falls below a defined threshold, or if they develop a new OI]. In Arm B, patients switch immediately to the salvage therapy regimen. [AS PER AMENDMENT 02/15/01: Patients who become pregnant during Step 1 of Arm A must be advised to begin their selected, individualized salvage therapy regimen or a modified salvage regimen. Patients who become pregnant during Step 2 of Arm A or Arm B have therapy evaluated and undergo any changes required by their pregnancy.] Patients in both arms are monitored for plasma HIV-1 RNA levels, CD4+ and CD8+ cell counts, and HIV drug resistance genotypes and phenotypes for a duration of 64 weeks from randomization. Patients in Arm A are also monitored for immune reactivation by measurement of T-cell subsets and plasma cytokines during treatment interruption. Patients may participate in a virology substudy (A5100s) and an immunology substudy (A5104s). [AS PER AMENDMENT 02/19/02: Patients who volunteer to participate in the substudies must be registered to the main study at the same time they are registered to a substudy.]

Conditions
HIV Infections
Being tested
Antiretroviral Treatment Interruption
Keywords
HIV-1, Drug Resistance, Microbial, Microbial Sensitivity Tests, Salvage Therapy, Anti-HIV Agents, Viral Load, Treatment Experienced
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antiretroviral Treatment InterruptionBehavioural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00011128
Sponsor's protocol ID
ACTG A5086
Other IDs
AACTG A5086, Substudy AACTG A5100s, Substudy AACTG A5104s
Status last verified
May 2004
First submitted
10 Feb 2001
Last updated
18 May 2015
Results posted
No

Publications

  • Montaner JS, Harrigan PR, Jahnke N, Raboud J, Castillo E, Hogg RS, Yip B, Harris M, Montessori V, O'Shaughnessy MV. Multiple drug rescue therapy for HIV-infected individuals with prior virologic failure to multiple regimens. AIDS. 2001 Jan 5;15(1):61-9. doi: 10.1097/00002030-200101050-00010.

    PubMed 11192869

  • Lorenzi P, Opravil M, Hirschel B, Chave JP, Furrer HJ, Sax H, Perneger TV, Perrin L, Kaiser L, Yerly S. Impact of drug resistance mutations on virologic response to salvage therapy. Swiss HIV Cohort Study. AIDS. 1999 Feb 4;13(2):F17-21. doi: 10.1097/00002030-199902040-00001.

    PubMed 10202819

  • Hance AJ, Lemiale V, Izopet J, Lecossier D, Joly V, Massip P, Mammano F, Descamps D, Brun-Vezinet F, Clavel F. Changes in human immunodeficiency virus type 1 populations after treatment interruption in patients failing antiretroviral therapy. J Virol. 2001 Jul;75(14):6410-7. doi: 10.1128/JVI.75.14.6410-6417.2001.

    PubMed 11413308

  • Clevenbergh P, Durant J, Halfon P, del Giudice P, Mondain V, Montagne N, Schapiro JM, Boucher CA, Dellamonica P. Persisting long-term benefit of genotype-guided treatment for HIV-infected patients failing HAART. The Viradapt Study: week 48 follow-up. Antivir Ther. 2000 Mar;5(1):65-70.

    PubMed 10846595

  • Delaugerre C, Valantin MA, Mouroux M, Bonmarchand M, Carcelain G, Duvivier C, Tubiana R, Simon A, Bricaire F, Agut H, Autran B, Katlama C, Calvez V. Re-occurrence of HIV-1 drug mutations after treatment re-initiation following interruption in patients with multiple treatment failure. AIDS. 2001 Nov 9;15(16):2189-91. doi: 10.1097/00002030-200111090-00016.

    PubMed 11684940

  • Benson CA, Vaida F, Havlir DV, Downey GF, Lederman MM, Gulick RM, Glesby MJ, Wantman M, Bixby CJ, Rinehart AR, Snyder S, Wang R, Patel S, Mellors JW; ACTG A5086 Study Team. A randomized trial of treatment interruption before optimized antiretroviral therapy for persons with drug-resistant HIV: 48-week virologic results of ACTG A5086. J Infect Dis. 2006 Nov 1;194(9):1309-18. doi: 10.1086/508289. Epub 2006 Sep 22.

    PubMed 17041858

  • Wang R, Bosch RJ, Benson CA, Lederman MM. Drug-resistant virus has reduced ability to induce immune activation. J Acquir Immune Defic Syndr. 2012 Dec 1;61(4):e60-3. doi: 10.1097/QAI.0b013e31827171d7. No abstract available.

    PubMed 23138731

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Antiretroviral Treatment Interruption in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00011128, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2015.

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