Who is sponsoring NCT00000838?

NCT00000838 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What condition does NCT00000838 study?

NCT00000838 studies HIV Infections.

What drugs are being tested in NCT00000838?

Interventions: Lamivudine, Stavudine, Zidovudine, Didanosine.

What is the status of NCT00000838?

NCT00000838 is currently COMPLETED.

Last reviewed 2021-10-27 · How we verify

A Phase II, Randomized Study of the Antiviral Activity and Resistance Interactions of Lamivudine (3TC) in Combination With Zidovudine (AZT), Stavudine (d4T), or Didanosine (ddI) Versus Monotherapy With ddI or d4T in HIV-Infected Individuals With 200 - 600 CD4+ Cells/mm3 and No Previous Nucleoside Experience

NCT00000838 Phase 2 COMPLETED

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

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	COMPLETED
Enrolment	256
Completion	1998-03

Conditions

HIV Infections

Interventions

Lamivudine
Stavudine
Zidovudine
Didanosine

Countries

United States, Puerto Rico