Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000838

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

256

Expected to finish

1998-03-01

Last updated by the study team

2021-11-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alabama Therapeutics CRS — Birmingham, Alabama, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Santa Clara Valley Med. Ctr. — San Jose, California, United States
• San Mateo County AIDS Program — San Mateo, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Queens Med. Ctr. — Honolulu, Hawaii, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Weiss Memorial Hosp. — Chicago, Illinois, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
• Washington U CRS — St Louis, Missouri, United States
• SUNY - Buffalo, Erie County Medical Ctr. — Buffalo, New York, United States
• Beth Israel Med. Ctr. (Mt. Sinai) — New York, New York, United States
• NYU Med. Ctr., Dept. of Medicine — New York, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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