Status:
COMPLETED
Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
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-infecte...
Detailed Description
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, suppresse...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
March 1 1998
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00000838
End Date
March 1 1998
Last Update
November 4 2021
Active Locations (32)
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1
Alabama Therapeutics CRS
Birmingham, Alabama, United States
2
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
3
Stanford CRS
Palo Alto, California, United States, 94115
4
Ucsd, Avrc Crs
San Diego, California, United States, 92103