The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs

NCT00001067 | Completed Phase 2

• 2 other identifiers: ACTG 29811274
• Study Type: interventional
• Target: 105
• Locations: 2 countries
• Sites: 13

Brief Summary

To determine drug efficacy and safety in HIV-infected patients treated with zidovudine ( AZT ) versus stavudine ( d4T ) versus both drugs. Also, to compare short- and long-term changes in magnitude of HIV RNA over time. Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option.

Conditions

HIV Infections

Keywords

Drug Therapy, Combination; AIDS-Related Complex; Zidovudine; Stavudine; Lamivudine

Interventions

Lamivudine DRUG

Stavudine DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Required:
• TMP / SMX, aerosolized pentamidine, or dapsone for PCP prophylaxis.
• Allowed:
• Atovaquone.
• IV pentamidine.
• TMP / SMX.
• Trimetrexate.
• Trimethoprim-dapsone.
• Clindamycin-primaquine.
• Topical antifungals.
• Clotrimazole.
• Ketoconazole.
• Fluconazole.
• Amphotericin B.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Serious underlying medical condition other than HIV such that life expectancy is less than 2 years.
• Malignancy requiring systemic cytotoxic chemotherapy.
• Active grade 2 or worse peripheral neuropathy.
• Concurrent Medication:
• Excluded:
• Antiretrovirals other than study drugs.
• Systemic cytotoxic chemotherapy.
• Foscarnet.
• Patients with the following prior conditions are excluded:
• Chronic diarrhea defined as three or more stools per day for 15 days, within 30 days prior to study entry.
• Unexplained temperature \>= 38.5 C for any 7 days within 30 days prior to study entry.
• Active participation in other experimental therapy within 30 days prior to study entry.
• Prior Medication:

Sponsors & Collaborators

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

Study Sites (13)

Alabama Therapeutics CRS

Birmingham, Alabama, 35294, United States

Location

Stanford CRS

Palo Alto, California, 94305, United States

Location

Ucsd, Avrc Crs

San Diego, California, 92103, United States

Location

Howard University Hosp., Div. of Infectious Diseases, ACTU

Washington D.C., District of Columbia, 20059, United States

Location

The Ponce de Leon Ctr. CRS

Atlanta, Georgia, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Washington U CRS

St Louis, Missouri, 63110, United States

Location

St. Louis ConnectCare, Infectious Diseases Clinic

St Louis, Missouri, 63112, United States

Location

Beth Israel Med. Ctr. (Mt. Sinai)

New York, New York, 10003, United States

Location

NYU Med. Ctr., Dept. of Medicine

New York, New York, 10016, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27599, United States

Location

The Ohio State Univ. AIDS CRS

Columbus, Ohio, 43210, United States

Location

Puerto Rico-AIDS CRS

San Juan, Puerto Rico

Location

Related Publications (3)

• Cadman J. 2, 4, 6, 8, who's afraid to phosphorylate? GMHC Treat Issues. 1998 Feb;12(2):6-8.

  PMID: 11365218 BACKGROUND

• Havlir DV, Friedland G, Pollard R, Tierney C, Smeaton L, Fox L, Richman DD. Combination zidovudine (ZDV) and stavudine (d4T) therapy versus other nucleosides: report of two randomized trials (ACTG 290 and 298). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:79 (abstract no 2)

  BACKGROUND

• Pollard RB, Tierney C, Havlir D, Tebas P, Fox L, Smeaton L, Richman D, Friedland GH. A phase II randomized study of the virologic and immunologic effect of zidovudine + stavudine versus stavudine alone and zidovudine + lamivudine in patients with >300 CD4 cells who were antiretroviral naive (ACTG 298). AIDS Res Hum Retroviruses. 2002 Jul 1;18(10):699-704. doi: 10.1089/088922202760072311.

  PMID: 12167276 BACKGROUND

MeSH Terms

Conditions

HIV Infections; AIDS-Related Complex

Interventions

Lamivudine; Stavudine; 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

• Havlir D

  STUDY CHAIR

• Pollard R

  STUDY CHAIR

• Richman D

  STUDY CHAIR

• Friedland G

  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: November 1, 1997
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (12); PR (1)