The Safety and Effectiveness of MK-639 and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1996
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.
Drug: Indinavir sulfate
||Endpoint Classification: Safety Study
Primary Purpose: Treatment
||Twelve-Month Study in HIV-1 Seropositive Retroviral-Naive Patients to Compare the Safety and Efficacy of MK-639 and Zidovudine (AZT) Administered Concomitantly to MK-639 Alone and Zidovudine (AZT) Alone
| Estimated Enrollment:
| Estimated Study Completion Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Patients with known hemophilia may be enrolled at the discretion of the investigator.
- 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.
Patients with the following symptoms or conditions are excluded:
- Acute hepatitis.
- Visceral Kaposi's sarcoma.
- Invasive cervical cancer.
- Active infection.
Anticipated immunosuppressive therapy.
No Contacts or Locations Provided
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 17, 2013
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors