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Home > "A" Clinical Trials Conditions > Antiviral Activity of and Resistance to Lamivudine in Combination with Zidovudine, Stavudine, or Didanosine  Antiviral Activity of and Resistance to Lamivudine in Combination with Zidovudine, Stavudine, or Didanosine
Antiviral Activity of and Resistance to Lamivudine in Combination with Zidovudine, Stavudine, or Didanosine
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate the efficacy, safety, and pharmacokinetics of lamivudine (3TC) combined with zidovudine (AZT), stavudine (d4T), or didanosine (ddI) in comparison with d4T or ddI monotherapy in HIV-infected patients with no prior nucleoside therapy. 3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations. One explanation is that the M184V mutation, which confers resistance to 3TC, suppresses AZT resistance. This benefit of 3TC may not extend to combination therapy with other nucleoside analogs.
Details: 3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations. One explanation is that the M184V mutation, which confers resistance to 3TC, suppresses AZT resistance. This benefit of 3TC may not extend to combination therapy with other nucleoside analogs. Patients are randomized to either a ddI limb or d4T limb, then randomized a second time to one of six treatment arms, as follows: ddI alone, d4T alone, 3TC/AZT (on both ddI and d4T limbs), 3TC/ddI, and 3TC/d4T. Treatment is given for 48 weeks. At study week 24, patients on monotherapy will have 3TC added to their regimen (in a blinded fashion). PER AMENDMENT 10/18/96: A treatment extension phase has been added to the study design in order to allow subjects who complete 48 weeks of therapy to remain on their same blinded treatment until approximately 2 months after the last enrolled subject completes 48 weeks on the study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - PCP prophylaxis. Patients must have: - HIV infection. - CD4 count 200 - 600 cells/mm3. - Life expectancy of at least 24 weeks. - Consent of parent or guardian if less than 18 years old. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Unexplained temperature >= 38.5 C for 7 consecutive days within 30 days prior to study entry. PER AMENDMENT 1/25/96: - A malignancy that requires systemic chemotherapies other than Kaposi's sarcoma. Concurrent Medication: Excluded: - Concurrent other antiretroviral or immunologic agents. - Other experimental therapies. - Systemic corticosteroids (except as adjuvant therapy for acute PCP) and other immunosuppressive drugs. - Systemic cytotoxic chemotherapy. - Induction or maintenance with foscarnet or ganciclovir (oral or IV). Patients with the following prior conditions are excluded: - History of acute or chronic pancreatitis. - History of grade 2 or higher peripheral neuropathy. Prior Medication: Excluded: - Antiretrovirals within 90 days prior to study entry. - More than 7 days total lifetime use of any antiretroviral nucleoside.
Total Enrollment: 256
Location and Contact Information:
Overall Study Official:
KuritzkesD, Study Chair,
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Illinois Masonic Med Ctr
Chicago, Illinois, 606575147
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: ACTG 306;
Study Start Date:
Record last reviewed: April 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000838
Other Hiv Infections Studies:
1. A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
2. Epicutaneous 1-Chloro-2, 4-dinitrobenzene (DNCB) Patch in HIV Infection.
3. Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
4. Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
5. A Comparison of Two Anti-HIV Treatment Plans
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Antiviral Activity of and Resistance to Lamivudine in Combination with Zidovudine, Stavudine, or Didanosine
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