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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00002451
Other study ID # 246U
Secondary ID 104-00
Status Active, not recruiting
Phase Phase 2
First received January 17, 2000
Last updated June 23, 2005

Study information

Verified date July 2002
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV) in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have never received anti-HIV therapy. This study will look at the effectiveness of this drug combination and side effects.


Description:

Patients entering this study initiate antiretroviral therapy. For 24 weeks patients receive daily dosages of IDV, RTV, 3TC, and d4T. Patients are seen at Day 1 and at Weeks 2, 4, 8, 12, 16, 20, and 24 for physical examinations, pregnancy testing, and blood sampling to monitor CD4 count and viral load. On Day 14, blood is drawn frequently for 24 hours for IDV and RTV pharmacokinetic sampling. The incidence of serious and drug-related adverse events and of adverse events leading to study discontinuation is tabulated.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 8
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria

Patients may be eligible for this study if they:

- Are HIV-positive.

- Are at least 18 years old.

- Have a viral load of 5,000 copies/ml or greater.

- Have a CD4 count of at least 50 cells/mm3.

Exclusion Criteria

Patients will not be eligible for this study if they:

- Have taken any antiretroviral (anti-HIV) agent.

- Are pregnant.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Indinavir sulfate

Ritonavir

Lamivudine

Stavudine


Locations

Country Name City State
United States Albany Med College Albany New York
United States Univ of Miami School of Medicine Miami Florida
United States SUNY at Stony Brook / Division of Infectious Diseases Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

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