# **REFERENCES**

1\. **REFERENCE INDEX**

> CORRELATION OF PK PARAMETERS WITH VIROLOGIC RESPONSE (PUBLISHED
> LITERATURE):

2.  P. Clevenbergh, J. Durant, R. Garraffo, P. Halfon, P. del
    Giudice, P. Simonet, N. Montagne, CAB Boucher, JM Schapiro, and P.
    Dellamonica, "Persisting Long Term Benefit Of Genotypic Guided
    Treatment In HIV Infected Patients Failing HAART And Importance Of
    Protease Inhibitor Plasma Levels. Viradapt Study, Week 48 Follow Up
    and Pharmacological Data" (source not provided)

3.  "Pharmacokinetic Enhancement of Other Protease Inhibitors with
    Ritonavir" from medscape.com

> P. Lorenzi, S. Yerly, K. Abderrakim, M. Fathi, O. T. Rutschmann, J.
> von Overbeck, D. Leduc, L. Perrin, B. Hirschel and the Swiss HIV
> Cohort Study,

"Toxicity, Efficacy, Plasma Drug Concentrations and Protease Mutations
In

Patients with Advanced HIV Infection Treated with Ritonavir Plus
Saquinavir",

AIDS 1997:11(12): F95-F99

4.  R. L. Murphy, JP. Sommadossi, M. Lamson, D.B. Hall, M. Myers, and A.
    Dusek, "Antiviral Effect and Pharmacokinetic Interaction between
    Nevirapine and Indinavir in Persons Infected with Human
    Immunodeficiency Virus Type I", Journal of Infectious Diseases 1999;
    179:1116-23

5.  M. F. Para, P. Meehan, J. Holden-Wiltse, M. Fischl, G. Morse, R.
    Shafer, L. M. Demeter, K.Wood, T. Nevin, N. Virani-Ketter, and W. W.
    Freimuth for the AIDS Clinical Trials Group Protocol 260 Team, "ACTG
    260: a Randomized, Phase I-II, Dose-Ranging Trial of the Anti-Human
    Immunodeficiency Virus Activity of Delavirdine Monotherapy",
    Antimicrobial Agents and Chemotherapy, June 1999; 43(6): 1373-1378

6.  R. Gieschke, B. Fotteler, N. Buss and JL. Steimer, "Relationships
    Between Exposure to Saquinavir Monotherapy and Antiviral Response in
    HIV-Positive Patients", Clin. Pharmacokinet 1999; 37(1): 75-86

7.  G. Gatti, A. Di Biagio, R. Casazza, C. De Pascalis, M. Bassetti, M.
    Cruciani, S. Vella, and D. Bassetti, "The Relationship Between
    Ritonavir Plasma Levels And Side-Effects: Implications For
    Therapeutic Drug Monitoring", AIDS 1999; 13(15): 2083-2089

8.  D. S. Stein, D. G. Fish, J. A. Bilello, S. L. Preston, G. L.
    Martineau and G. L. Drusano, "A 24-Week Open Label Phase I/II
    Evaluation of the HIV Protease Inhibitor MK-639 (Indinavir)", AIDS
    1996; 10(5): 485-492

9.  M. Harris, C. Durakovic, S. Rae, J. Raboud, S. Fransen, A.
    Shillington, B. Conway, and J. S. G. Montaner, "A Pilot Study of
    Nevirapine, Indinavir, and Lamivudine among Patients with Advanced
    Human Immunodeficiency Virus Disease Who Have Had Failure of
    Combination Nucleoside Therapy", Journal of Infectious Diseases
    1998; 177:1514-20

10. C. V. Fletcher, R. C. Brundage, R. P. Remmel, L. M. Page, D.
    Weller, N. R. Calles, C. Simon, and M.W. Kline, " Pharmacologic
    Characteristics of Indinavir, Didanosine, and Stavudine in Human
    Immunodeficiency Virus-Infected Children Receiving Combination
    Therapy", Antimicrobial Agents and Chemotherapy 2000; 44(4):
    1029-1034

11. E. P. Acosta, K. Henry, L. Baken, L. M. Page, and C.V. Fletcher,
    "Indinavir Concentrations and Antiviral Effect", Pharmacotherapy
    1999: 19(6): 708-712

12. **CORRELATION OF PK PARAMETERS WITH VIROLOGIC RESPONSE AND TOXICITY
    (ABSTRACTS):**

> #42259 R. M. W. Hoetelmans, M. H. E. Reijers, G. F. Weberling, S.
> Furriaans, and F. M. A. Lange, "The Rate of Decline of HIV-1 RNA in
> Plasma Correlates with Nelfinavir Concentrations in Plasma" (source
> not provided)
>
> #42261 R. M. W. Hoetelmans, R. P. G. Heeswijk, Van, P. L. Meenhorst,
> F. W. Mulder, W. A. Scheele, and F. H. Beijnen, "Plasma Concentrations
> of Saquinavir (SQV) Determine HIV-1 RNA Response Over A 48-Week
> Period" (source not provided)
>
> #5.3 D. M. Burger, A. M.C. Van Rossum, P. W. H. Hugen, S.P. M. Geelen,
> and R. De Groot for the Dutch Study Group for Children with HIV
> Infection, "The Indinavir (IDV)
> Area-Under-The-Plasma-Concentration-Time-Curve (AUC) in HIV-1-Infected
> Children Should Be Above 20mg/L.h to Obtain an Optimal Virological
> Response" (source not provided)
>
> #5.4 G. Gatti, A. Di Biagio, M. Mastropasqua, M. Bassetti, S. Vella,
> D. Bassetti and the ISS-IP-1 PK/PD study group, " The Relationship
> between Systemic Exposure to Indinavir and Virologic Efficacy"(source
> not provided)
>
> #12304 B. Kerr, Y. Pithavala, M. Zhang, M. Knowles, R. Daniels, and
>
> R. Anderson, "Virologic Response-Plasma Drug Concentration
> Relationship in Phase III Study of Nelfinavir Mesylate (VIRACEPT)",
> 12^th^ World AIDS Conference Programme Search
>
> #12372 J. Dieleman, I. C. Gyssens, M.E.M. van der Ende, S. de Marie,
> and D. M. Burger, "Urologic Complaints in Relation to Indinavir Plasma
> Levels in HIV-Infected Patients", 12^th^ World AIDS Conference
> Programme Search

13. **PK PARAMETERS IN THE SETTING OF PHARMACOLOGIC ENHANCEMENT
    (ABSTRACTS AND PUBLISHED LITERATURE):**

> \# 362 A. Saah, G. Winchell, M. Seniuk, D. Mehrotra, and P. Deutsch,
> "Multiple-dose Pharmacokinetics (PK) and Tolerability of Indinavir
> (IDV)-Ritonavir (RTV) Combinations In Healthy Volunteers (Merck 078)",
> 6^th^ Conference on Retroviruses and Opportunistic Infections, 1999,
> Chicago, Illinois
>
> #363 D. M. Burger, P. W. H. Hugen, J. M. Prins, M. E. Van De Ende, P.
> Reiss, and J. M. A. Lange, " Pharmacokinetics of Indinavir/ Ritonavir
> 800/ 100 mg BID regimen", 6^th^ Conference on Retroviruses and
> Opportunistic Infections, 1999, Chicago, Illinois

14. A. Hsu, G. R. Granneman, G. Cao, L. Carothers, A. Japour, T.
    El-Shourbagy, S. Dennis, J. Berg, K. Erdman, J. M. Leonard, and E.
    Sun, " Pharmacokinetic Interaction between Ritonavir and Indinavir
    in Healthy Volunteers", Antimicrobial Agents and Chemotherapy, 1998;
    42(11): 2784-2791

15. N. Shulman, A. Zolopa, D. Havlir, and J. Gallant, " Ritonavir
    Intensification..." (poster presentation)

R. M. E. van Praag, G. J. Weverling, P. Portegies, S. Jurriaans, X. J.
Zhou, M.L.

Turner-Folsy, J. P. Somadossi, D. M. Burger, R. M. W. Hoetelmans, J. M.
A.

Lange and J. M Prins, "Enhanced Penetration of Indinavir (IDV) in
Cerebrospinal

> Fluid and Semen after Addition of Low-Dose Ritonavir (RTV)", (poster
> presentation)

16. **GUIDANCE FOR INDUSTRY: PROVIDING CLINICAL EVIDENCE OF
    EFFECTIVENESS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS:**

Guidance for Industry: Providing Clinical Evidence of Effectiveness for
Human Drug and Biological Products, May 1998; Clinical 6: 1-20

17. **21 CFR 320.23 REFERENCE:**

21 CFR 320.23 Basis for demonstrating in vivo bioavailability or
bioequivalence