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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lamivudine
Stavudine
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Stavudine, Lamivudine

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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. Itraconazole. Rifabutin. Isoniazid. Pyrazinamide. Clofazimine. Clarithromycin. Azithromycin. Ethambutol. Amikacin. Ciprofloxacin. Ofloxacin. Pyrimethamine. Sulfadiazine. Clindamycin. Filgrastim ( G-CSF ). Up to 1000 mg/day acyclovir. Erythropoietin. Antibiotics. Antipyretics. Analgesics. Antiemetics. Rifampin. Concurrent Treatment: Allowed: Local radiation therapy. Patients must have: HIV infection. CD4 count 300 - 600 cells/mm3. NO history of AIDS. NO active opportunistic infection. NO prior nucleoside therapy. Life expectancy at least 2 years. Exclusion Criteria 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: Excluded: Prior nucleoside antiretrovirals of 1 week or longer duration. Any antiretroviral within 90 days prior to study entry. Non-nucleoside reverse transcriptase inhibitors and protease inhibitors within 30 days prior to study entry. Biologic response modifiers such as IL-2 and interferon within 30 days prior to study entry.

Sites / Locations

  • Alabama Therapeutics CRS
  • Stanford CRS
  • Ucsd, Avrc Crs
  • Howard University Hosp., Div. of Infectious Diseases, ACTU
  • The Ponce de Leon Ctr. CRS
  • Johns Hopkins Adult AIDS CRS
  • Washington U CRS
  • St. Louis ConnectCare, Infectious Diseases Clinic
  • Beth Israel Med. Ctr. (Mt. Sinai)
  • NYU Med. Ctr., Dept. of Medicine
  • Unc Aids Crs
  • The Ohio State Univ. AIDS CRS
  • Puerto Rico-AIDS CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001067
Brief Title
The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs
Official Title
A Phase II Randomized Study of the Virologic and Immunologic Effects of Zidovudine Plus Lamivudine (3TC) Versus d4T Versus Zidovudine Plus d4T in HIV-Infected Patients With CD4 Cell Counts Between 300-600/mm3 and No Previous Nucleoside Experience
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1997 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
Detailed Description
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. Patients are randomized to receive d4T alone, AZT alone, or both in combination for at least 12 weeks. After week 12, 3TC is added to the combination arm. Treatment continues for up to 48 weeks (was a total of 48 weeks, amended 3/26/96).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Stavudine, Lamivudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
105 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Itraconazole. Rifabutin. Isoniazid. Pyrazinamide. Clofazimine. Clarithromycin. Azithromycin. Ethambutol. Amikacin. Ciprofloxacin. Ofloxacin. Pyrimethamine. Sulfadiazine. Clindamycin. Filgrastim ( G-CSF ). Up to 1000 mg/day acyclovir. Erythropoietin. Antibiotics. Antipyretics. Analgesics. Antiemetics. Rifampin. Concurrent Treatment: Allowed: Local radiation therapy. Patients must have: HIV infection. CD4 count 300 - 600 cells/mm3. NO history of AIDS. NO active opportunistic infection. NO prior nucleoside therapy. Life expectancy at least 2 years. Exclusion Criteria 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: Excluded: Prior nucleoside antiretrovirals of 1 week or longer duration. Any antiretroviral within 90 days prior to study entry. Non-nucleoside reverse transcriptase inhibitors and protease inhibitors within 30 days prior to study entry. Biologic response modifiers such as IL-2 and interferon within 30 days prior to study entry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Havlir D
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pollard R
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richman D
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Friedland G
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Therapeutics CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Stanford CRS
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Ucsd, Avrc Crs
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Howard University Hosp., Div. of Infectious Diseases, ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20059
Country
United States
Facility Name
The Ponce de Leon Ctr. CRS
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis ConnectCare, Infectious Diseases Clinic
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Beth Israel Med. Ctr. (Mt. Sinai)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
NYU Med. Ctr., Dept. of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Unc Aids Crs
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The Ohio State Univ. AIDS CRS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Puerto Rico-AIDS CRS
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
11365218
Citation
Cadman J. 2, 4, 6, 8, who's afraid to phosphorylate? GMHC Treat Issues. 1998 Feb;12(2):6-8.
Results Reference
background
Citation
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)
Results Reference
background
PubMed Identifier
12167276
Citation
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.
Results Reference
background

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

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