HIV InfectionsNCT00000874

A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing (GART) Compared With Antiretroviral Management Without Plasma GART

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine the short-term virologic and immunologic effects of using plasma genotypic antiretroviral resistance testing (GART) results (interpreted by study virologists AS PER AMENDMENT 9/17/97) in the management of therapy for antiretroviral-experienced patients failing on one of the following regimens: 1. Read more about this study

Who is it for?: Ages 13 years and older
Conditions the study is for: HIV Infections
How many people: 148 participants
Where: 24 sitesUnited States
Study dates: Aug 1997to Mar 1999
Phase: Observational
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 13 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: HIV-infected participants currently failing their antiretroviral regimens

Who may be able to join

Patients must have:
Documentation of a CD4+ cell count between 50 and 500/mm3 prior to the baseline visit [within 6 weeks prior to baseline visit AS PER AMENDMENT 9/17/97].
Documentation of either a plasma HIV RNA > 50,000 copies/ml by the Roche Amplicor HIV-1 assay or > 25,000 copies/ml by the Chiron bDNA assay, performed within 30 days prior to the baseline visit. [AS PER AMENDMENT 9/17/97: Documentation of either a plasma HIV RNA level >20,000 copies/ml by the Roche Amplicor HIV-1 assay or >10,000 copies/ml by the Chiron bDNA assay, performed within 6 weeks prior to baseline visit.]
Documentation of a 3-fold rise in plasma HIV RNA level (using the same assay) or a previously documented plasma HIV RNA at an undetectable level while on the current antiretroviral regimen. [AS PER AMENDMENT 9/17/97: Documentation that the screening plasma HIV RNA level is a 3-fold rise from a previous determination (using the same assay) or documentation of a previous plasma HIV RNA <500 copies/ml while on the current antiretroviral regimen.]
Signed, informed consent from a parent or legal guardian for patients < 18 years of age.
Prior Medication: Included:
At least an 18-month cumulative history of antiretroviral therapy [AS PER AMENDMENT 9/17/97: At least a 12-month cumulative history of antiretroviral therapy].

Who cannot join

Co-existing Condition:
Patients with the following conditions are excluded:
Intercurrent illness (which in the clinician's judgment could influence the HIV RNA level) within 2 weeks prior to, or since, obtaining blood for the screening HIV RNA measurement [within 2 weeks prior to obtaining screening HIV RNA specimen or within 2 weeks prior to baseline visit AS PER AMENDMENT 11/26/97].
Unwillingness or inability to change antiretroviral therapy.
Unwillingness to wait up to 30 days after the GART baseline visit to change current triple treatment therapy regimen [AS PER AMENDMENT 9/17/97: Unwillingness to wait until baseline plasma GART results are available to change the current triple therapy regimen].
Accessibility to previous genotypic or phenotypic resistance testing results.

Show all 24Show fewer

Co-enrollment in a clinical trial with anti-HIV drugs.
Concurrent Medication:
Excluded:
Agents with anti-HIV activity.
Initiation of treatment with IL-2, interferon, or adefovir dipivoxil.
Anti-influenza or other vaccines.
Prior Medication:
Excluded:
[AS PER AMENDMENT 11/26/97:
Use of immunomodulators within 2 weeks prior to obtaining the screening plasma HIV RNA specimen or within 2 weeks prior to the baseline visit.
Use of any anti-HIV agents, other than drugs in the qualifying triple antiretroviral regimen, within the past 16 weeks.]
Patients must currently be on one of the following triple antiretroviral regimens for at least 16 weeks:
ZDV + 3TC + IDV
ZDV + 3TC + SQV
ZDV + 3TC + RTV
d4T + 3TC + IDV. [AS PER AMENDMENT 11/26/97: Patients must currently be on a triple antiretroviral regimen that includes a single protease inhibitor (IDV, SQV, RTV, or NFV) and two licensed NRTIs for at least 16 weeks.]
Concurent Treatment: Excluded:
Vaccination within 2 weeks prior to, or since, obtaining blood for the screening HIV RNA measurement [within 2 weeks prior to obtaining screening plasma HIV RNA specimen or within 2 weeks prior to the baseline visit AS PER AMENDMENT 11/26/97].

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Partners in Research / New Mexico
Albuquerque, New Mexico, 87131
Partners Research
Albuquerque, New Mexico, 87131
T A Ferrill Regional HIV Clinic
Albuquerque, New Mexico, 87131
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Mercer Area Early Intervention Services
Camden, New Jersey, 08103
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Alpine Family Medicine / Janowski
Denver, Colorado, 80204
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 80204
S Denver Infectious Diseases Specialists
Denver, Colorado, 80204
VA Med Ctr
Denver, Colorado, 80204
Wayne State Univ / WSU / DMC HIV / AIDS Program
Detroit, Michigan, 48201
Henry Ford Hosp
Detroit, Michigan, 48202
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037
North Jersey Community Research Initiative
Newark, New Jersey, 07103
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Saint Joseph's Hosp
Philadelphia, Pennsylvania, 19107
The Research and Education Group
Portland, Oregon, 97210
Richmond AIDS Consortium
Richmond, Virginia, 23298
Community Consortium / UCSF
San Francisco, California, 94110
Community Consortium of San Francisco
San Francisco, California, 94110
Montgomery County Health Dept
Washington D.C., District of Columbia, 20422
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422

Other trials in United States

About this study

zidovudine (ZDV) + (lamivudine) 3TC + (indinavir) IDV
ZDV + 3TC + saquinavir (SQV)
ZDV + 3TC + ritonavir (RTV)
stavudine (d4T) + 3TC + IDV. [AS PER AMENDMENT 11/26/97: To determine the short-term effects of using plasma GART in the management of antiretroviral-experienced patients failing on a triple drug regimen that includes a single protease inhibitor (indinavir [IDV], saquinavir [SQV], ritonavir [RTV], or nelfinavir [NFV]) and two licensed nucleoside reverse transcriptase inhibitors (NRTIs).] A growing body of evidence suggests that antiretroviral resistance is associated with an increased risk of disease progression and death. All commercially available antiretrovirals and many of those in development have been associated with resistance. Fortunately, techniques are available to define HIV genotypic resistance in "real time" as compared to techniques that measure phenotypic resistance that is not practical in a clinical setting. Using genotypic antiretroviral resistance testing (GART) results, along with other currently available markers, may lead to improved treatment decisions compared with using currently available markers alone.

Read the detailed description

A growing body of evidence suggests that antiretroviral resistance is associated with an increased risk of disease progression and death. All commercially available antiretrovirals and many of those in development have been associated with resistance. Fortunately, techniques are available to define HIV genotypic resistance in "real time" as compared to techniques that measure phenotypic resistance that is not practical in a clinical setting. Using genotypic antiretroviral resistance testing (GART) results, along with other currently available markers, may lead to improved treatment decisions compared with using currently available markers alone.

128 patients are randomized to GART or no GART within each of four strata defined by current antiretroviral regimen:

ZDV plus 3TC plus IDV
ZDV plus 3TC plus SQV
ZDV plus 3TC plus RTV
d4T plus 3TC plus IDV. Each of the four strata contains 22 patients with CD4+ counts of 50 - 199/mm3 and 11 patients with CD4+ counts of 200 - 500/mm3. Upon randomization, clinicians determine a treatment strategy with supplied baseline GART results (GART arm) or without them (no-GART arm). All patients remain on the triple antiretroviral regimen initiated at the randomization visit until at least the 8-week visit. At this time, changes in treatment will be allowed based on an inadequate response to therapy.

[AS PER AMENDMENT 9/17/97: 128 patients are randomized to therapy based on GART results or therapy not based on these results. Patients are stratified into 8 groups defined by current antiretroviral regimen (ZDV/3TC/IDV vs. ZDV/3TC/SQV vs. ZDV/3TC/RTV vs. d4T/3TC/IDV) and screening CD4+ count (50-199 vs. 200-500). Management of patients assigned to the GART group is based on recommendations of study virologists after independent review of patient plasma GART results in addition to current clinical practice. Up to four different treatment regimens using only licensed drugs may be recommended, ranked but considered approximately therapeutically equivalent. The management of patients assigned to the no-GART group is based on current clinical practice and includes only licensed antiretrovirals.] [AS PER AMENDMENT 11/26/97: 160 patients are randomized to GART or no GART within each of 8 strata defined by current antiretroviral regimen (NRTI-1 plus NRTI-2 plus IDV vs. NRTI-1 plus NRTI-2 plus SQV vs. NRTI-1 plus NRTI-2 plus RTV vs. NRTI-1 plus NRTI-2 plus NFV) and screening CD4+ cell count.]

Conditions: HIV Infections
Keywords: HIV-1, Drug Therapy, Combination, Zidovudine, Stavudine, Drug Resistance, Microbial, HIV Protease Inhibitors, CD4 Lymphocyte Count, Ritonavir, Lamivudine, Indinavir, RNA, Viral, Genotype, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Medical subject headings: HIV Infections

What participants receive

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

Study groups in NCT00000874
Study group	Role	What they receive
1		Participants who are failing a regimen of ZDV, 3TC, and IDV
2		Participants who are failing a regimen of ZDV, 3TC, and SRQ
3		Participants who are failing a regimen of ZDV, 3TC, and RTV
4		Participants who are failing a regimen of d4T, 3TC, and IDV

Timeline

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

Aug 1997Mar 1999

First posted31 Aug 2001 (estimated)
Study startAug 1997
Primary completionJan 1999
Study completionMar 1999

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00000874
Sponsor's protocol ID: CPCRA 046
Other IDs: 11598
Status last verified: Sep 2013
First submitted: 2 Nov 1999
Last updated: 1 Oct 2013
Results posted: No

Publications

Winters MA, Baxter JD, Mayers DL, Wentworth DN, Hoover ML, Neaton JD, Merigan TC. Frequency of antiretroviral drug resistance mutations in HIV-1 strains from patients failing triple drug regimens. The Terry Beirn Community Programs for Clinical Research on AIDS. Antivir Ther. 2000 Mar;5(1):57-63.
PubMed 10846594
Mayers D. A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing (GART) Compared With Antiretroviral Management Without Plasma GART. (abstract no.124)
Baxter JD, Mayers DL, Wentworth DN, Neaton JD, Merigan TC. A pilot study of the short-term effects of antiretroviral management based on plasma genotypic antiretroviral resistance testing (GART) in patients failing antiretroviral therapy. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:206 (abstract no LB8)
Baxter JD, Mayers DL, Wentworth DN, Neaton JD, Hoover ML, Winters MA, Mannheimer SB, Thompson MA, Abrams DI, Brizz BJ, Ioannidis JP, Merigan TC. A randomized study of antiretroviral management based on plasma genotypic antiretroviral resistance testing in patients failing therapy. CPCRA 046 Study Team for the Terry Beirn Community Programs for Clinical Research on AIDS. AIDS. 2000 Jun 16;14(9):F83-93. doi: 10.1097/00002030-200006160-00001.
PubMed 10894268
Baxter JD, Merigan TC, Wentworth DN, Neaton JD, Hoover ML, Hoetelmans RM, Piscitelli SC, Verbiest WH, Mayers DL; CPCRA 046 Study Team for the Terry Beirn Community Programs for Clinical Research on AIDS. Both baseline HIV-1 drug resistance and antiretroviral drug levels are associated with short-term virologic responses to salvage therapy. AIDS. 2002 May 24;16(8):1131-8. doi: 10.1097/00002030-200205240-00006.
PubMed 12004271

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing (GART) Compared With Antiretroviral Management Without Plasma GART
ClinicalTrials.gov ID: NCT00000874
Acronym / sponsor ID: CPCRA 046
Conditions: HIV Infections
Keywords: HIV-1, Drug Therapy, Combination, Zidovudine, Stavudine, Drug Resistance, Microbial, HIV Protease Inhibitors, CD4 Lymphocyte Count, Ritonavir
Study type: Observational
Recruitment status: Completed
Enrolment: 148 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: Aug 1997
Primary completion: Jan 1999 (actual)
Study completion: Mar 1999 (actual)
First posted: 31 Aug 2001 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

zidovudine (ZDV) + (lamivudine) 3TC + (indinavir) IDV
ZDV + 3TC + saquinavir (SQV)
ZDV + 3TC + ritonavir (RTV)
stavudine (d4T) + 3TC + IDV. [AS PER AMENDMENT 11/26/97: To determine the short-term effects of using plasma GART in the management of antiretroviral-experienced patients failing on a triple drug regimen that includes a single protease inhibitor (indinavir [IDV], saquinavir [SQV], ritonavir [RTV], or nelfinavir [NFV]) and two licensed nucleoside reverse transcriptase inhibitors (NRTIs).] A growing body of evidence suggests that antiretroviral resistance is associated with an increased risk of disease progression and death. All commercially available antiretrovirals and many of those in development have been associated with resistance. Fortunately, techniques are available to define HIV genotypic resistance in "real time" as compared to techniques that measure phenotypic resistance that is not practical in a clinical setting. Using genotypic antiretroviral resistance testing (GART) results, along with other currently available markers, may lead to improved treatment decisions compared with using currently available markers alone.

Detailed description

128 patients are randomized to GART or no GART within each of four strata defined by current antiretroviral regimen:

ZDV plus 3TC plus IDV
ZDV plus 3TC plus SQV
ZDV plus 3TC plus RTV
d4T plus 3TC plus IDV. Each of the four strata contains 22 patients with CD4+ counts of 50 - 199/mm3 and 11 patients with CD4+ counts of 200 - 500/mm3. Upon randomization, clinicians determine a treatment strategy with supplied baseline GART results (GART arm) or without them (no-GART arm). All patients remain on the triple antiretroviral regimen initiated at the randomization visit until at least the 8-week visit. At this time, changes in treatment will be allowed based on an inadequate response to therapy.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
1	–	–Participants who are failing a regimen of ZDV, 3TC, and IDV
2	–	–Participants who are failing a regimen of ZDV, 3TC, and SRQ
3	–	–Participants who are failing a regimen of ZDV, 3TC, and RTV
4	–	–Participants who are failing a regimen of d4T, 3TC, and IDV

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: HIV-infected participants currently failing their antiretroviral regimens

Key inclusion criteria (7 listed)

Documentation of a CD4+ cell count between 50 and 500/mm3 prior to the baseline visit [within 6 weeks prior to baseline visit AS PER AMENDMENT 9/17/97].
Documentation of either a plasma HIV RNA > 50,000 copies/ml by the Roche Amplicor HIV-1 assay or > 25,000 copies/ml by the Chiron bDNA assay, performed within 30 days prior to the baseline visit. [AS PER AMENDMENT 9/17/97: Documentation of either a plasma HIV RNA level >20,000 copies/ml by the Roche Amplicor HIV-1 assay or >10,000 copies/ml by the Chiron bDNA assay, performed within 6 weeks prior to baseline visit.]
Documentation of a 3-fold rise in plasma HIV RNA level (using the same assay) or a previously documented plasma HIV RNA at an undetectable level while on the current antiretroviral regimen. [AS PER AMENDMENT 9/17/97: Documentation that the screening plasma HIV RNA level is a 3-fold rise from a previous determination (using the same assay) or documentation of a previous plasma HIV RNA <500 copies/ml while on the current antiretroviral regimen.]
Signed, informed consent from a parent or legal guardian for patients < 18 years of age.
At least an 18-month cumulative history of antiretroviral therapy [AS PER AMENDMENT 9/17/97: At least a 12-month cumulative history of antiretroviral therapy].

Key exclusion criteria (24 listed)

Intercurrent illness (which in the clinician's judgment could influence the HIV RNA level) within 2 weeks prior to, or since, obtaining blood for the screening HIV RNA measurement [within 2 weeks prior to obtaining screening HIV RNA specimen or within 2 weeks prior to baseline visit AS PER AMENDMENT 11/26/97].
Unwillingness or inability to change antiretroviral therapy.
Unwillingness to wait up to 30 days after the GART baseline visit to change current triple treatment therapy regimen [AS PER AMENDMENT 9/17/97: Unwillingness to wait until baseline plasma GART results are available to change the current triple therapy regimen].
Accessibility to previous genotypic or phenotypic resistance testing results.
Co-enrollment in a clinical trial with anti-HIV drugs.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
Background: PubMed 10846594Winters MA, Baxter JD, Mayers DL, Wentworth DN, Hoover ML, Neaton JD, Merigan TC. Frequency of antiretroviral drug resistance mutations in HIV-1 strains from patients failing triple drug regimens. The Terry Beirn Community Programs for Clinical Research on AIDS. Antivir Ther. 2000 Mar;5(1):57-63.
BackgroundMayers D. A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing (GART) Compared With Antiretroviral Management Without Plasma GART. (abstract no.124)
BackgroundBaxter JD, Mayers DL, Wentworth DN, Neaton JD, Merigan TC. A pilot study of the short-term effects of antiretroviral management based on plasma genotypic antiretroviral resistance testing (GART) in patients failing antiretroviral therapy. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:206 (abstract no LB8)
Background: PubMed 10894268Baxter JD, Mayers DL, Wentworth DN, Neaton JD, Hoover ML, Winters MA, Mannheimer SB, Thompson MA, Abrams DI, Brizz BJ, Ioannidis JP, Merigan TC. A randomized study of antiretroviral management based on plasma genotypic antiretroviral resistance testing in patients failing therapy. CPCRA 046 Study Team for the Terry Beirn Community Programs for Clinical Research on AIDS. AIDS. 2000 Jun 16;14(9):F83-93. doi: 10.1097/00002030-200006160-00001.
Background: PubMed 12004271Baxter JD, Merigan TC, Wentworth DN, Neaton JD, Hoover ML, Hoetelmans RM, Piscitelli SC, Verbiest WH, Mayers DL; CPCRA 046 Study Team for the Terry Beirn Community Programs for Clinical Research on AIDS. Both baseline HIV-1 drug resistance and antiretroviral drug levels are associated with short-term virologic responses to salvage therapy. AIDS. 2002 May 24;16(8):1131-8. doi: 10.1097/00002030-200205240-00006.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Baxter J study chair

Mayers D study chair

Merigan T study chair

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 24 sites in United States.

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 7 inclusion and 24 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: finished, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 NCT00000874, which also lists 5 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 1 Oct 2013.