A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients

NCT00001085 | Completed Phase 2

• 2 other identifiers: ACTG 34711317
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 15

Brief Summary

To determine the proportion of patients whose plasma HIV-1 RNA level remains below a detectable level (less than 500/ml) after 24 weeks of study therapy with either 141W94 monotherapy or 141W94 plus zidovudine (ZDV) and lamivudine (3TC). To determine the safety and tolerability of 141W94 monotherapy and the combination of 141W94 plus 3TC in patients with HIV infection. Although dramatic inhibition of HIV-1 replication is achieved with ritonavir or indinavir monotherapy, in both cases maximum suppression required combination treatment together with nucleoside analog RT inhibitors. This study tests the hypothesis that monotherapy with 141W94 doses that result in Cmin levels far in excess of the IC90 corrected for plasma protein binding for HIV-1 can achieve the same virologic and immunologic effects in terms of magnitude and durability, as has been observed with combinations of other protease inhibitors plus nucleoside analogs.

Conditions

HIV Infections

Keywords

HIV-1; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; Zidovudine; HIV Protease Inhibitors; Lamivudine; RNA, Viral; VX 478; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load

Interventions

Amprenavir DRUG

Lamivudine DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Chemoprophylaxis for Pneumocystis carinii pneumonia is required for all patients who have a CD4 cell count \<= 200 cells/mm3.
• Topical and/or oral antifungal agents, except for those listed in excluded medications.
• Treatment, maintenance or chemoprophylaxis with approved agents for opportunistic infections as clinically indicated, unless listed in excluded medications.
• All antibiotics as clinically indicated.
• Systemic corticosteroid use for \<= 21 days for acute problems is permitted as medically indicated; chronic systemic corticosteroid use is not permitted.
• Recombinant erythropoietin and granulocyte colony-stimulating factor as medically indicated.
• Regularly prescribed medications such as:
• antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives (a barrier method is also required for this study), megestrol acetate, testosterone or any other medications, as medically indicated.
• Alternative therapies such as vitamins, acupuncture and visualization techniques are permitted (excluding herbal medications).
• NOTE:
• Patients should report the use of these therapies; alternative therapies will be recorded.
• Patients must have:
• HIV-1 infection as documented by ELISA and confirmed.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Any active infection requiring acute treatment within 14 days prior to entry.
• A malignancy that requires systemic therapy other than minimal Kaposi's sarcoma.
• NOTE:
• Patients with minimal Kaposi's sarcoma, defined as \<= 5 cutaneous lesions and no visceral disease or tumor-associated edema, will be allowed to enroll as long as they do not require systemic therapy for Kaposi's sarcoma.
• Patients with the following prior symptoms and conditions are excluded:
• Inability to tolerate ZDV 500-600 mg daily if ZDV was administered previously. Intolerance to ZDV is defined as any grade toxicity that resulted in a dose reduction or termination of ZDV.
• Prior Medication:
• Excluded:
• Any 3TC therapy prior to entry.
• Any HIV-1 protease inhibitor therapy prior to study entry (e.g., saquinavir, ritonavir, indinavir, nelfinavir, 141W94).
• Any immunomodulator therapy within 30 days prior to entry.
• Active immunization within 30 days prior to entry.
• Any antiretroviral therapy change within 30 days prior to study screening.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (15)

Alabama Therapeutics CRS

Birmingham, Alabama, 35294, United States

Location

USC CRS

Los Angeles, California, 900331079, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, 331361013, United States

Location

The Ponce de Leon Ctr. CRS

Atlanta, Georgia, 30308, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Cook County Hosp. CORE Ctr.

Chicago, Illinois, 60612, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612, United States

Location

Bmc Actg Crs

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02215, United States

Location

St. Louis ConnectCare, Infectious Diseases Clinic

St Louis, Missouri, 63112, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 275997215, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

• Murphy RL, Gulick RM, DeGruttola V, D'Aquila RT, Eron JJ, Sommadossi JP, Currier JS, Smeaton L, Frank I, Caliendo AM, Gerber JG, Tung R, Kuritzkes DR. Treatment with amprenavir alone or amprenavir with zidovudine and lamivudine in adults with human immunodeficiency virus infection. AIDS Clinical Trials Group 347 Study Team. J Infect Dis. 1999 Apr;179(4):808-16. doi: 10.1086/314668.

  PMID: 10068575 BACKGROUND

• Murphy R, Degruttola V, Gulick R, D'Aquila R, Eron J, Sommadossi JP, Smeaton L, Currier J, Tung R, Kuritzkes D. 141W94 with or without zidovudine/3TC in patients with no prior protease inhibitor or 3TC therapy-ACTG 347. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:175 (abstract no 512)

  BACKGROUND

• Eron JJ Jr, Smeaton LM, Fiscus SA, Gulick RM, Currier JS, Lennox JL, D'Aquila RT, Rogers MD, Tung R, Murphy RL. The effects of protease inhibitor therapy on human immunodeficiency virus type 1 levels in semen (AIDS clinical trials group protocol 850). J Infect Dis. 2000 May;181(5):1622-8. doi: 10.1086/315447. Epub 2000 Apr 26.

  PMID: 10783117 BACKGROUND

• Eron J, Smeaton L, Degruttola V, Schock J, Fiscus S, Tung R, Gulick R, Murphy R. The effects of amprenavir (APV) alone or in combination with ZDV/3TC, on HIV-1 levels in semen: a substudy of ACTG 347. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:109 (abstract no 222)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

amprenavir; Lamivudine; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine

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: September 1, 1998
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (15)