A Phase 2 interventional study of Lamivudine and Stavudine in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 32 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-11-04.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
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.
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.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 256 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,445 studies on the registry; 182 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 300 (75%) have results posted.
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Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
PER AMENDMENT 1/25/96:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lamivudine · Stavudine · Zidovudine · Didanosine
National Institute of Allergy and Infectious Diseases (NIAID) →