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CompletedNCT00002443Updated Jun 24, 2005

The Safety and Effectiveness of MK-639 and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

An interventional study of Indinavir sulfate and Zidovudine in HIV Infections, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Merck Sharp & Dohme LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
780
Ages
18 Years and older
Sex
All
01

Study summary

To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.

Read the detailed description

Patients are randomized to 1 of 3 groups for 12 months of treatment. Group 1 receives MK-639 plus AZT. Group 2 receives MK-639 alone. Group 3 receives AZT alone. Safety and tolerability are assessed by the incidence of clinical and laboratory adverse experiences. Blood and urine samples are collected for safety assessment and to determine CD4 cell counts and serum viral RNA levels. If therapy with MK-639 alone or with AZT is found to be generally safe and clinically efficacious, patients who have completed the study will have the opportunity to continue in an extension study protocol on a treatment regimen including MK-639.

02

Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 780 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

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Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients must have:

  • HIV seropositivity.
  • Average CD4 count between 50 and 500 cells/mm3 based on 2 separate pre-study determinations at least 1 week apart.

Note:

  • Patients with known hemophilia may be enrolled at the discretion of the investigator.

Prior Medication:

Excluded:

  • Any protease inhibitor.
  • Significant prior use (greater than 2 weeks) of nucleoside analogues.
  • Chronic therapy for an active opportunistic infection. (Allowed:
  • Prophylaxis with aerosolized pentamidine, trimethoprim/sulfamethoxazole, dapsone, topical antifungals, and isoniazid).
  • Investigational agents or immunomodulators within 30 days prior to study entry.

Exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Acute hepatitis.
  • Lymphoma.
  • Visceral Kaposi's sarcoma.
  • Invasive cervical cancer.
  • Active infection.

Concurrent Medication:

Excluded:

Anticipated immunosuppressive therapy.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Masking
Double
Enrollment
780 participants

Interventions

  • DrugIndinavir sulfate
  • DrugZidovudine
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002443
Lead sponsor
Merck Sharp & Dohme LLC
First posted
Aug 31, 2001
Completion
Jan 1996
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 1996. You cannot join it, but the record below documents what was studied.

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