NCT00001095

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

October 1, 1999

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationZidovudineNevirapineStavudineHIV Protease InhibitorsLamivudineVX 478Reverse Transcriptase InhibitorsAnti-HIV AgentsViral Load

Interventions

Indinavir sulfateDRUG
AmprenavirDRUG
NevirapineDRUG
LamivudineDRUG
StavudineDRUG
ZidovudineDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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:
  • +14 more criteria

You may not qualify if:

  • 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.
  • 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:
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Emory Univ

Atlanta, Georgia, 30308, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Boston Med Ctr

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess - West Campus

Boston, Massachusetts, 02215, United States

Location

St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, 63112, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Univ of North Carolina

Chapel Hill, North Carolina, 275997215, United States

Location

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Related Publications (2)

  • 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.

    PMID: 11181147BACKGROUND

  • 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)

    BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

IndinaviramprenavirNevirapineLamivudineStavudineZidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Officials

  • Murphy R

    STUDY CHAIR

  • Gulick R

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

October 1, 1999

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(12)