FindTrial
Sign In

A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC

A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002155
Enrollment
600
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir

Brief summary

To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine (AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan ) plus AZT plus lamivudine ( 3TC ) versus MK-639 alone versus AZT/3TC.

Detailed description

AZT-experienced patients are randomized to receive MK-639/AZT/3TC or MK-639 alone or AZT/3TC. Additionally, patients who have received \< 6 months of AZT or who are intolerant but received prior 3TC or who require concomitant rifampin therapy may receive open-label MK-639.

Interventions

DRUGIndinavir sulfate
DRUGLamivudine
DRUGZidovudine

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Concurrent Medication: Allowed for all patients: * Standard prophylaxis for opportunistic infections. * Continuation of treatment for opportunistic infection. Allowed for open-label study patients: * Rifampin. Patients must have: * HIV positivity. * CD4 count \<= 50 cells/mm3. * More than 6 months of prior AZT (blinded study only). NOTE: * Patients on the open-label study must have AZT intolerance or have \< 6 months of prior AZT. Prior Medication: Required for blinded study patients: * \> 6 months of prior AZT. Required for open-label study patients: * \< 6 months of prior AZT. Allowed for open-label study patients: * Prior 3TC.

Exclusion criteria

Concurrent Medication: Excluded in all patients: * Immunosuppressants. Excluded in blinded study patients: * AZT, ddI, ddC, or d4T. * Rifampin. Excluded in open-label study patients: * 3TC. Prior Medication: Excluded in all patients: * Prior protease inhibitors. * Investigational agents and immunomodulators within 30 days prior to study entry. * Immunosuppressants within 2 weeks prior to study entry. Excluded in blinded study patients: * Any prior 3TC. * AZT, ddI, ddC, or d4T within 2 weeks prior to study entry. Excluded in open-label study patients: 3TC within 30 days prior to study entry.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026