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HIV InfectionsPhase 2NCT00001095

A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir

A Phase 2 study testing Indinavir sulfate, Amprenavir and Nevirapine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 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 proportion of patients treated with amprenavir, zidovudine (ZDV), stavudine (D4T) and lamivudine (3TC) whose HIV-1 RNA level remains below the level of detection during 96 weeks of therapy. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
HIV Infections
What is being tested?
Indinavir sulfate, Amprenavir and Nevirapine
How many people
94 participants
Where
12 sitesUnited States
Study dates
Start not givento Oct 1999
Phase
Phase 2
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

Who may be able to join

  • Concurrent Medication:
  • Required:
  • Chemoprophylaxis for Pneumocystis carinii pneumonia (for patients with a CD4+ cell count less than or equal to 200 cells/mm3.
  • Allowed:
  • Topical and/or oral antifungal agents.
  • Treatment, maintenance or chemoprophylaxis with approved agents for opportunistic infections.
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  • Antibiotics.
  • Systemic corticosteroid use for 21 days or less.
  • Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgrastim).
  • Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives (not as a sole form of contraception), megestrol acetate, and testosterone.
  • Alternative therapies such as vitamins, acupuncture, and visualization techniques.
  • [AS PER AMENDMENT 2/27/98:
  • Current use of triple therapy with amprenavir/3TC/ZDV (or d4T) for Arm A patients.
  • Current use of quadruple therapy with IDV/NVP/3TC/d4T for Arm B patients.]
  • Patients must have:
  • HIV-positive status.
  • Successful response to treatment in ACTG 347 as measured by HIV RNA less than 500 copies/ml (Arm A) OR unsuccessful response to treatment in ACTG 347 or another regimen containing amprenavir OR an increase in plasma HIV RNA above the nadir value to greater than 5,000 copies/ml or by at least one log10 at any time (Arm B) OR intolerance to a regimen containing amprenavir.
  • Consent for patients less than 18 years of age.
  • [AS PER AMENDMENT 2/27/98:
  • Arm A patients must have:
  • HIV RNA less than 500 copies/ml on at least one occasion within 60 days of entry while previously enrolled in ACTG 347 and in one of the following categories: currently receiving amprenavir/3TC/ZDV (or d4T) or randomized to monotherapy arm of ACTG 347 and received open-label amprenavir/3TC/ZDV (or d4T).
  • Arm B patients must have:
  • Failed prior amprenavir therapy, whether on ACTG 347 or not, i.e., HIV RNA greater than or equal to 500 copies/ml after at least 16 weeks of amprenavir and confirmed within 1-6 weeks OR treatment failure that mandated early permanent discontinuation of randomized ACTG 347 study drugs and defined as HIV RNA of at least one log 10 above the nadir (to at least 5,000 copies/ml) or HIV RNA level above the baseline value before 16 weeks of amprenavir and confirmed within 1-6 weeks.
  • Initially randomized to triple therapy arm of ACTG 347 with two plasma HIV-1 RNA values of at least 500 copies/ml taken within 60 days prior to study entry and at least 1-6 weeks apart or initially receive open-label amprenavir/3TC/ZDV (or d4T) and with two HIV RNA levels of at least 500 copies/ml, regardless of duration of treatment with amprenavir/3TC/ZDV (or d4T).
  • Documented intolerance to any of the reverse transcriptase inhibitors or attempted nevirapine therapy allowed. Arm C patients must have:
  • Previously enrolled on ACTG 347 and elected to receive a treatment regimen other than amprenavir/3TC/ZDV (or d4T) or IDV/NVP/3TC/d4T.]
  • Prior Medication: Required:
  • Amprenavir therapy [AS PER AMENDMENT 2/27/98:
  • amprenavir therapy (Arm A and B patients only)].

Who cannot join

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Arm A:
  • Inability to tolerate amprenavir, ZDV, or 3TC.
  • Arm B:
  • Inability to tolerate d4T, NVP, or 3TC.
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  • Active infection requiring acute treatment within 14 days prior to study entry.
  • Malignancy that requires systemic therapy (patients with minimal Kaposi's sarcoma are not excluded provided they do not require systemic therapy).
  • [AS PER AMENDMENT 2/27/98:
  • Patients with the following conditions or symptoms are excluded: Arm A:
  • Any detection of plasma HIV RNA greater than 500 copies/ml after subject has switched to triple therapy for at least 16 weeks.
  • Inability to tolerate amprenavir, ZDV (or d4T), or 3TC.
  • Malignancy that requires systemic therapy (minimal Kaposi's sarcoma allowed provided systemic therapy is not required) Arm A and B patients only.]
  • Concurrent Medication:
  • Excluded:
  • Non-protocol-specified antiretroviral agents.
  • Immunomodulators that affect immunologic or virologic indices, such as systemic corticosteroids (more than 21 days), thalidomide, or cytokines.
  • Concomitant use of rifabutin and/or rifampin.
  • Investigational drugs without specific approval.
  • Systemic cytotoxic chemotherapy.
  • Oral astemizole, carbamazepine, dexamethasone, ketoconazole, itraconazole, phenobarbital, phenytoin, terfenadine, cisapride, triazolam, terfenadine, astemizole, and midazolam.
  • Prior Medication:
  • [AS PER AMENDMENT 2/27/98: Excluded:
  • Prior protease inhibitor therapy except amprenavir (Arm A patients).
  • Prior protease inhibitor therapy except amprenavir and IDV (Arm B patients).
  • Excluded within 14 days prior to entry:
  • Investigational drugs or immunomodulators (except amprenavir) without specific consent of protocol chair(s) (Arm A patients).
  • Immunomodulators that affect immunologic or virologic indices, such as systemic corticosteroids, thalidomide or cytokines, unless approved by protocol chair(s) (Arm B patients).
  • Oral astemizole, carbamazepine, dexamethasone, ketoconazole, itraconazole, phenobarbital, phenytoin, terfenadine, cisapride, triazolam, midazolam, ergot alkaloids, or drugs containing derivatives of ergot alkaloids.]

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Emory Univ

    Atlanta, Georgia, 30308

  • Boston Med Ctr

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess - West Campus

    Boston, Massachusetts, 02215

  • Univ of North Carolina

    Chapel Hill, North Carolina, 275997215

  • Cook County Hosp

    Chicago, Illinois, 60612

  • Univ of Colorado Health Sciences Ctr

    Denver, Colorado, 80262

  • Univ of Southern California / LA County USC Med Ctr

    Los Angeles, California, 900331079

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Univ of Pennsylvania at Philadelphia

    Philadelphia, Pennsylvania, 19104

  • St Louis Regional Hosp / St Louis Regional Med Ctr

    St Louis, Missouri, 63112

  • Julio Arroyo

    West Columbia, South Carolina, 29169

Other trials in United States

About this study

Official title: A Phase II Study of 1) Amprenavir (141W94/VX478) Plus 3TC Plus ZDV (or d4T) or 2) IDV Plus NVP Plus 3TC Plus d4T in Subjects Previously Treated With Amprenavir and 3) Other Treatment Regimens (Observational ARM) in Subjects Previously Treated With Amprenavir

To determine the proportion of patients treated with amprenavir, zidovudine (ZDV), stavudine (D4T) and lamivudine (3TC) whose HIV-1 RNA level remains below the level of detection during 96 weeks of therapy. To determine the proportion of patients treated with indinavir (IDV), nevirapine (NVP), 3TC, and d4T whose HIV-1 RNA level decreases and then remains below the level of detection, during the 96-week therapy period. To determine the viral effects, safety, tolerability, and pharmacokinetics of amprenavir in combination with zidovudine, stavudine, and lamivudine. [AS PER AMENDMENT 2/27/98: To determine the proportion of patients with undetectable plasma HIV RNA, by treatment and baseline RNA cohort (either detectable or undetectable). To determine the durability of these regimens by estimating the distribution of time to loss of virologic suppression (or equivalently, time to virologic failure), by treatment and baseline RNA cohort.] This study allows patients who have successfully participated in ACTG 347 or other trials involving amprenavir to continue treatment with amprenavir, ZDV, d4T, and 3TC. Additionally, this study provides patients whose HIV-1 RNA was not reduced to undetectable levels or who had a significant increase in plasma levels ("treatment failures") the opportunity to change to a potentially more active regimen that includes indinavir, nevirapine, lamivudine, and stavudine.

Read the detailed description

This study allows patients who have successfully participated in ACTG 347 or other trials involving amprenavir to continue treatment with amprenavir, ZDV, d4T, and 3TC. Additionally, this study provides patients whose HIV-1 RNA was not reduced to undetectable levels or who had a significant increase in plasma levels ("treatment failures") the opportunity to change to a potentially more active regimen that includes indinavir, nevirapine, lamivudine, and stavudine.

Patients with HIV RNA less than 500 copies/ml on a regimen containing amprenavir are treated on Arm A; those with greater than or equal to 500 copies while on or intolerant to a regimen containing amprenavir are treated on Arm B.

Arm A: Amprenavir + ZDV + d4T + 3TC. Arm B: IND + NVP + 3TC + d4T. Patients enrolled in Arm A who fail therapy may roll over to Arm B. Patients in Arm B who fail therapy discontinue study medications and seek best available treatment.

[AS PER AMENDMENT 2/27/98: Patients with HIV RNA less than 500 copies/ml currently on triple therapy with amprenavir + 3TC + ZDV (or d4T if ZDV-intolerant) are treated on ARM A. Patients with HIV RNA greater than or equal to 500 copies/ml, who have been intolerant to a regimen containing amprenavir or who were previously enrolled on ACTG 347 who elected to receive a treatment regimen other than amprenavir + ZDV (or d4T) + 3TC or IDV + NVP + 3TC + d4T or other regimens are assigned to Arm C.

Arm A: Amprenavir + ZDV* plus 3TC. Arm B: IDV + NVP + 3TC + d4T*. Arm C: Observation only. Patients are followed for the duration of the study.

  • Patients intolerant of ZDV may elect to receive d4T. Patients intolerant of IDV may take study-provided nelfinavir. *Patients who switched to open-label IDV/NVP/3TC/d4T prior to enrollment on this study and who were intolerant to any of the study medications may enroll into Arm B with appropriate substitution of the intolerant study drug(s).

Patients initially assigned to Arm A who are intolerant of amprenavir or who fail therapy have the option of receiving Arm B therapy. Patients initially assigned to Arm B who are intolerant of any of the assigned study drugs may make an appropriate antiretroviral substitution (with approval of the protocol chair).]

Conditions
HIV Infections
Being tested
Indinavir sulfate, Amprenavir, Nevirapine, Lamivudine, Stavudine
Keywords
Drug Therapy, Combination, Zidovudine, Nevirapine, Stavudine, HIV Protease Inhibitors, Lamivudine, VX 478, 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.

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)
  2. Study completionOct 1999

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 2
Primary purpose
Treatment
Enrolment
94 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001095
Sponsor's protocol ID
ACTG 373
Other IDs
11334
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • Gulick RM, Smeaton LM, D'Aquila RT, Eron JJ, Currier JS, Gerber JG, Acosta E, Sommadossi JP, Tung R, Snyder S, Kuritzkes DR, Murphy RL; AIDS Clinical Trials Group 373 Study Team. Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir-experienced subjects: AIDS Clinical Trials Group protocol 373. J Infect Dis. 2001 Mar 1;183(5):715-21. doi: 10.1086/318820. Epub 2001 Jan 30.

    PubMed 11181147

  • Gulick RM, Smeaton L, D'Aquila RT, Eron JJ, Currier JS, Degruttola V, Gerber JG, Sommadossi JP, Tung R, Kuritzkes DR, Murphy RL. Indinavir (IDV), nevirapine (NVP), stavudine (d4T) and lamivudine (3TC) for amprenavir (APV)-experienced subjects: ACTG 373. 7th Conf Retro and Opportun Infect. 2000 Jan 30 - Feb 2 (abstract no 526)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Indinavir sulfate, Amprenavir and Nevirapine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 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 29 inclusion and 29 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 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 NCT00001095, which also lists 2 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 4 Nov 2021.

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